March 27, 2017
FDA Alerts Veterinarians and Pet Food Manufacturers about Potential Presence of Thyroid Hormones in Pet Foods and Treats
The U.S. Food and Drug Administration is advising pet owners and caretakers, veterinarians, and the pet food industry to be aware that pet food and treats made with livestock gullets (meat from the throat region) have the potential to contain thyroid tissue and thyroid hormones. Pets that eat food or treats containing thyroid hormones may develop hyperthyroidism, a disease that is rare in dogs and usually triggered by thyroid cancer.
Symptoms of hyperthyroidism include excessive thirst and urination, weight loss, increased appetite, restlessness, hyperactivity, elevated heart rate, rapid and/or labored breathing, vomiting, and diarrhea. Continued exposure to excess thyroid hormones can cause damage to the heart and in some cases, death.
The FDA is issuing this alert now after a recent Center for Veterinary Medicine investigation into reports of three dogs in different households that showed signs of hyperthyroidism. In these cases, extensive testing on all three dogs conducted at a reference laboratory showed elevated thyroid hormone in the blood, but ruled out thyroid cancer. Reference lab interviews with the dogs’ owners revealed that all three dogs had been fed BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food for Adult Dogs and/or Wellness 95% Beef Topper for Dogs.
Based on the recommendation of the reference lab’s consulting veterinarian, the feeding of these dog foods was discontinued. After the dogs stopped eating these products for a few weeks, their clinical signs disappeared and thyroid hormone levels returned to normal. An FDA lab tested unopened cans of BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food for Adult Dogs and Wellness 95% Beef Topper for Dogs and confirmed that they contained active thyroid hormone. The source of thyroid hormones is likely from the use of gullets from which the thyroid glands were not completely removed before adding to pet food or treats.
After consulting with the FDA, both WellPet (the maker of Wellness) and Blue Buffalo (the maker of Blue Wilderness) initiated voluntary recalls of select lots of the affected products on March 17, 2017.
WellPet voluntarily recalled of certain lots of 13.2 ounce cans of Wellness 95% Beef Topper for Dogs with best-by dates of 02 FEB 19, 29 AUG 19, and 30 AUG 19 printed on the bottom of the can. The UPC Code is 076344894506.
Blue Buffalo Company voluntarily recalled of one lot of 12.5-ounce cans BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food for Adult Dogs with a best-by date of June 7, 2019 printed on the bottom of the can. The UPC code is 840243101153.
The FDA appreciates the cooperation and swift action taken by both firms to address this issue. If your dog has eaten either of these foods and is showing symptoms of hyperthyroidism, discontinue feeding of these foods and consult your veterinarian, making sure to provide your dog’s dietary history, including what the dog has been eating, how much, and for how long.
Consumers who have any of the recalled food should not feed it to their animals and can refer to the company press releases for further instructions about returns/refunds.
Questions about whether a particular pet food or pet treat product contains livestock gullets and/or thyroid hormones should be directed to the product manufacturer.
The FDA provides more detailed information about the issue of thyroid hormones in pet food in its Letter to Veterinary Professionals and Letter to Industry.
Additional Information:
Letter to Veterinary Professionals - Exogenous Hyperthyroidism and Thyroid Hormones in Pet Food
Letter to Industry - Thyroid Hormones in Pet Food
Wellpet Voluntarily Recalls a Limited Amount of One Recipe of Canned Topper For Dogs Due to Potential Elevated Levels of Naturally Occurring Beef Thyroid Hormone
Blue Buffalo Voluntarily Recalls One Lot of BLUE Wilderness® Rocky Mountain Recipe TM Red Meat Dinner Wet Food For Adult Dogs Due to Potential Health Risk
How to Report a Pet Food Complaint
https://www.fda.gov/AnimalVeterinary/Ne ... 548883.htm
ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
..........Traci
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
FDA takes action against 14 companies for selling illegal cancer treatments
April 25, 2017
The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.
“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs. “We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult a health care professional about proper prevention, diagnosis and treatment of cancer.”
It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses. The illegally sold products cited in the warning letters posted today include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices). They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims.
The FDA has requested responses from the 14 companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure, injunction and/or criminal prosecution.
As part of the FDA’s effort to protect consumers from cancer health fraud, the FDA has issued more than 90 warning letters in the past 10 years to companies marketing hundreds of fraudulent products making cancer claims on websites, social media and in stores. Although many of these companies have stopped selling the products or making fraudulent claims, numerous unsafe and unapproved products continue to be sold directly to consumers due in part to the ease with which companies can move their marketing operations to new websites. The FDA continues to monitor and take action against companies promoting and selling unproven treatments in an effort to minimize the potential dangers to consumers and to educate consumers about the risks.
The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://www.fda.gov/NewsEvents/Newsroom ... 554698.htm
MORE INFORMATION:
The products are marketed and sold without FDA approval, most commonly on websites or social media platforms. They have not been reviewed by FDA for safety and efficacy, and can be dangerous to both people and pets.
Questions and Answers: FDA alerts companies to stop the illegal sale of products claiming to treat cancer
Consumer Update: Products Claiming to “Cure” Cancer Are a Cruel Deception
MedWatch: Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure
FDA Voice Blog: FDA Takes Action Against Fraudulent Cancer Products
FDA's Flickr - Illegally Sold Cancer Products
April 25, 2017
The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.
“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs. “We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult a health care professional about proper prevention, diagnosis and treatment of cancer.”
It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses. The illegally sold products cited in the warning letters posted today include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices). They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims.
The FDA has requested responses from the 14 companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure, injunction and/or criminal prosecution.
As part of the FDA’s effort to protect consumers from cancer health fraud, the FDA has issued more than 90 warning letters in the past 10 years to companies marketing hundreds of fraudulent products making cancer claims on websites, social media and in stores. Although many of these companies have stopped selling the products or making fraudulent claims, numerous unsafe and unapproved products continue to be sold directly to consumers due in part to the ease with which companies can move their marketing operations to new websites. The FDA continues to monitor and take action against companies promoting and selling unproven treatments in an effort to minimize the potential dangers to consumers and to educate consumers about the risks.
The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://www.fda.gov/NewsEvents/Newsroom ... 554698.htm
MORE INFORMATION:
The products are marketed and sold without FDA approval, most commonly on websites or social media platforms. They have not been reviewed by FDA for safety and efficacy, and can be dangerous to both people and pets.
Questions and Answers: FDA alerts companies to stop the illegal sale of products claiming to treat cancer
Consumer Update: Products Claiming to “Cure” Cancer Are a Cruel Deception
MedWatch: Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure
FDA Voice Blog: FDA Takes Action Against Fraudulent Cancer Products
FDA's Flickr - Illegally Sold Cancer Products
..........Traci
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
Smallbatch Pets Inc. Voluntarily Recalls Frozen 2LB Chicken Blend For Dogs And Cats Due To Possible Salmonella Health Risk
May 5, 2017-
Smallbatch Pets Inc. of Portland, Oregon is voluntarily recalling two lots of frozen 2lbs. chicken blend for dogs and cats, brand name Smallbatch, due to the potential to be contaminated with Salmonella.
Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Symptoms of infection in people include nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.
Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
No pet or consumer illnesses from this product have been reported to date. However, because of their commitment to safety and quality, Smallbatch Pets is conducting a voluntary recall of this product. Consumers should also follow the Simple Handling Tips published on the Smallbatch Pets package, when disposing of the affected product.
The potentially affected lots of 2lbs. chicken blend were distributed to retail pet food stores in States CA, CO, OR, WA through pet food retailers/distributors. Two hundred and eighty-two cases of this product were sold between the dates of 2/1/17 – 5/5/17.
The affected products are sold frozen in 2lbs. bags. The products affected by this recall are identified with the following manufacturing codes and the “Best By” date is located on the back of the package.
LOT / UPC /Best By Date
D032 / 705105970974 / 2/1/2018
E058 / 705105970974 / 2/27/2018
This recall was initiated after routine testing by the Food and Drug Administration of a 2lb bag of chicken blend, that was collected at a distributor, revealed the presence of Salmonella.
This recall is being made with the knowledge of the U.S. Food and Drug Administration.
Consumers who have purchased the above lots of Chicken Blend are urged to stop feeding them to their dogs or cats and return product to place of purchase for a full refund or dispose of them immediately.
We do apologize for any inconvenience and for all consumer questions, please call us at 888-507 2712, Monday – Friday, 9:00AM - 4:00PM PST or email us at info@smallbatchpets.com.
Product label photo also included here:
https://www.fda.gov/Safety/Recalls/ucm557128.htm
May 5, 2017-
Smallbatch Pets Inc. of Portland, Oregon is voluntarily recalling two lots of frozen 2lbs. chicken blend for dogs and cats, brand name Smallbatch, due to the potential to be contaminated with Salmonella.
Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Symptoms of infection in people include nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.
Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
No pet or consumer illnesses from this product have been reported to date. However, because of their commitment to safety and quality, Smallbatch Pets is conducting a voluntary recall of this product. Consumers should also follow the Simple Handling Tips published on the Smallbatch Pets package, when disposing of the affected product.
The potentially affected lots of 2lbs. chicken blend were distributed to retail pet food stores in States CA, CO, OR, WA through pet food retailers/distributors. Two hundred and eighty-two cases of this product were sold between the dates of 2/1/17 – 5/5/17.
The affected products are sold frozen in 2lbs. bags. The products affected by this recall are identified with the following manufacturing codes and the “Best By” date is located on the back of the package.
LOT / UPC /Best By Date
D032 / 705105970974 / 2/1/2018
E058 / 705105970974 / 2/27/2018
This recall was initiated after routine testing by the Food and Drug Administration of a 2lb bag of chicken blend, that was collected at a distributor, revealed the presence of Salmonella.
This recall is being made with the knowledge of the U.S. Food and Drug Administration.
Consumers who have purchased the above lots of Chicken Blend are urged to stop feeding them to their dogs or cats and return product to place of purchase for a full refund or dispose of them immediately.
We do apologize for any inconvenience and for all consumer questions, please call us at 888-507 2712, Monday – Friday, 9:00AM - 4:00PM PST or email us at info@smallbatchpets.com.
Product label photo also included here:
https://www.fda.gov/Safety/Recalls/ucm557128.htm
..........Traci
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
FDA ISSUES WARNING LETTER TO EVANGER'S FOR VIOLATIONS REGARDING PENTOBARBITOL IN PET FOOD
https://www.fda.gov/ICECI/EnforcementAc ... 565516.htm
Evanger's Dog & Cat Food Co 6/29/17
U.S. Food & Drug Administration
Chicago District Office
550 W. Jackson Blvd., Suite 1500
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: 312) 596-4187
WARNING LETTER
FY17-HAFE6-01
June 29, 2017
UPS NEXT DAY
SIGNATURE REQUIRED
Ms. Holly N. Sher, President
Mr. Joel A. Sher, Vice President
Evanger’s Dog & Cat Food Company, Inc.
221 Wheeling Road
Wheeling, Illinois 60090
The U.S. Food and Drug Administration (FDA) conducted an inspection of your low-acid canned food manufacturing facility located at 221 Wheeling Road, Wheeling, Illinois between January 10, 2017 and February 14, 2017. The inspection was conducted in response to a consumer complaint that indicated five dogs became sick, with one of the dogs dying, after consuming “Evanger’s Hunk of Beef in Au Jus”
chunk meat product.
As a result of inspectional evidence collected during the investigation, including supplier traceback, facility inspection, and samples collected by FDA, we found serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. You can find FDA regulations and the FD&C Act through links on FDA’s home page at http://www.fda.gov.
FDA analysis of your canned chunk meat dog foods, including “Evanger’s - Braised Beef Chunks,” “Evanger’s - Hand Packed Hunk of Beef in Au Jus,” and “Against the Grain - Grain Free Pulled Beef with Gravy” chunk meat products revealed that the products were contaminated with pentobarbital. This substance causes your animal food products to be adulterated under section 402(a)(1) of the FD&C
Act [21 U.S.C. §342(a)(1)] because they bear or contain a poisonous or deleterious substance which may render them injurious to health. Furthermore, the introduction or delivery for introduction into interstate commerce of an adulterated food violates section 301(a) of the FD&C Act [21 U.S.C. §331(a)].
Pentobarbital sodium is a drug approved for anesthetizing certain animals. However, though unapproved for this use, pentobarbital sodium is often used as a euthanasia agent. There is not a residue tolerance established for pentobarbital. Therefore, when it is used in food-producing animals, it can render any resulting meat products adulterated. Use of the pentobarbital-contaminated meat product in
animal food can cause serious illness or injury to animals consuming such products.
At the conclusion of the January-February 2017 inspection, the FDA investigators issued a six (6) item Form FDA-483, Inspectional Observations, listing violations found at your facility. Two (2) of the most
significant violations are as follows:
1) Your low-acid canned dog food product labeled in part “EVANGER’S *** HAND PACKED HUNK OF BEEF AUS JUS ***” and coded “1816E06HB13 *** BEST JUNE 2020” was found by chemical analysis to contain the barbiturate drug pentobarbital.
2) Your low-acid canned dog food product labeled in part “AGAINST the GRAIN *** GRAIN FREE PULLED BEEF with Gravy *** DINNER FOR DOGS *** NET WT 12 OZ ***” and coded 2415E01ATB12 BEST DEC 2019” was found by chemical analysis to contain the barbiturate drug pentobarbital.
In addition, further sampling conducted by FDA found pentobarbital in the following finished product lots of pet food:
1) Evanger’s Braised Beef Chunks, lot code 2016E08BBW11 Best Aug 2020.
2) Evanger’s Hunk of Beef Au Jus, lot code 1816E14HBC18 Best June 2020.
3) Evanger’s Hunk of Beef Au Jus, lot code 1816E02HB12 Best June 2020.
4) Evanger’s Hunk of Beef Au Jus, lot code 1316E23HB09 Best Jan 2020.
5) Evanger’s Hunk of Beef Au Jus, lot code 1816E03HB17 Best June 2020.
To avoid distributing adulterated products, it is essential that your firm have a system in place to ensure the safety of your processed animal food. Aspects of such a system may include, for example: attaining assurances that the raw meat material received at your facility is from source animals that contain no violative chemical residues, including drugs, and implementing identification and/or other procedures to track the raw meat material from receipt, throughout the manufacturing process, and into the finished products. It is your responsibility to ensure that your overall procedures and systems adequately prevent and control adulteration so that you are not manufacturing and distributing an adulterated product.
We acknowledge your voluntary action of conducting a recall for all of your whole beef chunk meat products manufactured between December 2015 and January 2017. In addition, we have received and reviewed your firm’s correspondence dated 2/4/2017, 2/21/2017, 4/4/2017, and 5/23/2017 regarding your corrective actions as discussed below:
In your firm’s correspondence dated 5/18/17, it was stated that the contamination was isolated to a specific supplier of beef material and you discontinued doing business with the supplier. However, you did not provide documentation or other evidence to FDA showing that the supplier in question is the only one who supplied the contaminated raw materials that went into all your recalled products. As such, FDA is unable to evaluate the adequacy of this response.
In your firm’s correspondence dated 5/18/17, it was stated that if any amount of pentobarbital were to be found in any of your ground loaf products, it would be in an amount that a laboratory would deem as being within the possibility of error and well within the range that FDA had previously deemed not be a health or safety concern in pet foods. FDA does not agree with your assessment that the process of grinding will dilute any pentobarbital present in the loaf products to non-detectable or safe levels. The agency notes that there is no tolerance level for pentobarbital in pet food.
In your firm’s correspondence dated 5/18/17, it was stated that your corrective action includes conducting random pentobarbital tests of finished products prior to shipment into the market to ensure that the raw materials are unadulterated. FDA has concerns about using random finished product testing as evidence that all lots of your finished products are unadulterated. The samples collected by FDA during this investigation demonstrate that pentobarbital contamination is not homogeneous throughout all units in a lot. Therefore, random testing of finished product may not be representative of all units of your products. Furthermore, finished product testing cannot mitigate the risk of pentobarbital in your raw material.
In your firm’s correspondence dated 5/18/17, it was indicated that all current and new suppliers must provide Evanger’s with letters of guarantee for their products. FDA has concerns that relying solely on a quality guarantee may not ensure the safety of the source material used in the production of your finished pet food. You should consider conducting site audits and/or a review of your supplier’s procedures to verify that the supplier has in fact implemented proper controls to prevent the use of contaminated source material as indicated in their letter of guarantee.
In your firm’s correspondence dated 4/4/17, it was requested to donate the recalled product to an animal shelter. FDA does not agree that analyzing individual units from recalled lots and finding those units negative for pentobarbital contamination provides sufficient assurance that the remaining units are not adulterated. As can be observed in the samples collected by FDA, the pentobarbital contamination is not homogeneous throughout all units in a lot. Therefore, FDA does not find it acceptable to donate any recalled products and instead recommends destruction of all remaining units.
Please be advised that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. You are responsible for ensuring that your facility operates in compliance with the FD&C Act and all applicable regulations. The specific violation(s) noted in this letter are symptomatic of serious problems in your firm’s manufacturing and quality assurance systems.
You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
In addition to the above violations, we further note the following:
During the inspection, your firm could not provide assurances from your suppliers that your raw materials had not been associated with the use of pentobarbital. In addition, your firm could not provide documentation showing the internal traceability of raw materials from receipt throughout the manufacturing process and into the finished product. Therefore, your firm could not definitively determine whether any of your other products contained the beef that went into the recalled products and has no assurances that the pentobarbital contamination could be traced to a single supplier. Please note that your facility will be subject to the CGMPs for food for animals (21 CFR 507, subpart B) beginning September 2017. Animal food that is not manufactured, processed, packed, and held according to CGMPs may be considered adulterated (21 CFR 507.1(a)(1)(i-ii)). Some items to remember as you bring your facility into compliance:
Management of the establishment must ensure that all operations in the manufacturing, processing, packing, and holding of animal food (including operations directed to receiving, inspecting, transporting, and segregating) are conducted in accordance with the current good manufacturing practice requirements of this subpart (21 CFR 507.25(a)(1)).
Management of the establishment must ensure adequate precautions are taken so that plant operations do not contribute to the contamination of animal food, animal food-contact surfaces, and animal food-packaging materials (21 CFR 507.25(a)(5)).
Management of the establishment must ensure all animal food manufacturing, processing, packing, and holding is conducted under such conditions and controls as are necessary to minimize the potential for the growth of undesirable microorganisms to protect against the contamination of animal food (21 CFR 507.25(a)( 8 ).
Raw materials and other ingredients must be examined to ensure they are suitable for manufacturing and processing into animal food (21 CFR 507.25(b)(1)).
We encourage you to review our draft Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals. This draft guidance provides further explanation and examples about how these requirements can be met. You will find the draft guidance located at:
https://www.fda.gov/downloads/AnimalVet ... 499200.pdf.
In addition to compliance with the CGMPs, in the future you must also comply with hazard analysis and risk-based preventive controls requirements (21 CFR 507, subpart C and E), unless an exemption applies (21 CFR 507.5). According to these subparts, a preventive controls qualified individual (PCQI) must prepare, or oversee the preparation of, a written hazard analysis to identify known or reasonably foreseeable hazards. The PCQI, or designee, must evaluate identified known or reasonably foreseeable hazards to determine if your firm has any hazards requiring a preventive control to significantly minimize or prevent the hazard. One type of preventive control is a supply-chain applied control, which would be implemented if a firm were relying on their supplier to control a hazard requiring a preventive control. A supply-chain-applied control must be written, and must include certain verification activities (and documentation of these verification activities). Verification activities may include onsite audits; sampling or testing of the raw material; review of the supplier’s records by the receiving facility; or other appropriate supplier verification activities based on the risk associated with the ingredient or the supplier.
Lastly, during the inspection, it was noted that individuals at Evanger’s Dog and Cat Food Company, Inc. are involved in the operation of two other firms, (b)(4), and (b)(4). We note that the new CGMP and hazard analysis and risk-based preventive controls requirements would also apply to any manufacturing, processing, packing, or holding of animal food by these firms unless an exemption applies.
Section 743 of the FD&C Act, 21 U.S.C. §379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection, 21 U.S.C. §379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.
Please notify in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. You should include in your response any documentation, including photographs, of the corrections you have taken or other useful information that would assist us in evaluating your corrections. If your planned corrections will occur over time or you cannot complete all corrections within fifteen (15) working days, please state the reason for the delay and include a timetable for implementation of those corrections.
Your written response should be directed to:
Nicholas F. Lyons
Director of Compliance
Food & Drug Administration
Office of Regulatory Affairs
550 West Jackson Blvd.
Chicago, IL 60661
Refer to the Unique Identification Number (Case # 518544) when replying. If you have questions regarding this letter, please contact Mr. Lyons by phone at (312) 596-4220 or via email at
Nicholas.Lyons@fda.hhs.gov.
Sincerely,
/s/
William R. Weissinger, M.S.
Chicago District Director
Office of Human and Animal Food Operations, Division 6 East
https://www.fda.gov/ICECI/EnforcementAc ... 565516.htm
..........Traci
ADMIN NOTE: PLEASE READ THE FOLLOWING TWO POSTS CAREFULLY, SALMONELLA AND LISTERIA CAN BE DEADLY IN BOTH PETS AND HUMANS!
FDA Investigates Outbreak of Salmonella Infections Linked to Raws for Paws Ground Turkey Food for Pets
February 9, 2018 -
The U.S. Food and Drug Administration, along with the Minnesota Department of Agriculture and Minnesota Department of Health, is investigating two Salmonella Reading illnesses in Minnesota that are linked to Raws for Paws Ground Turkey Food for Pets.
* The FDA advises consumers not to feed pets certain lots of Raws For Paws Ground Turkey Food for Pets because the product may be contaminated with Salmonella, the presence of which has the potential to cause salmonellosis in humans and animals. The product is sold online by Christofersen Meats Company, Inc., dba Swanson Meats, in Minneapolis, MN (no relation to Swanson Meals).
* The Minnesota Department of Health reports that two children in a single household became sick from Salmonella Reading (S. Reading).
* Testing performed by the Minnesota Department of Health and the Minnesota Department of Agriculture demonstrated that the same strain of S. Reading found in the ill children was also found in four samples of Raws for Paws Ground Turkey Food for Pets that was used to feed the family dog.
* Christofersen Meats Company, Inc. recalled the Raws for Paws product on February 5, 2018 and began directly notifying its customers on the same day.
* This outbreak is of particular public health importance because of the potential hazard to both human and animal health.
What is the Problem and What is Being Done About It?
The U.S. Food and Drug Administration, along with the Minnesota Department of Agriculture and Minnesota Department of Health, is investigating two Salmonella Reading (S. Reading) illnesses in Minnesota that are linked to all lots of Raws for Paws Ground Turkey Food for Pets manufactured on October 12, 2017.
The Minnesota Department of Health reports that two children in a single household were exposed to contaminated Raws for Paws product, which was used to feed the family dog. One child’s illness resulted in septicemia (blood infection) and osteomyelitis, a painful and serious bone infection.
Testing performed by the Minnesota Department of Health and the Minnesota Department of Agriculture demonstrated that the same strain of S. Reading found in the ill children was also found in four samples of Raws for Paws Ground Turkey Food for Pets that was used to feed the family pet.
On February 5, 2018, Christofersen Meats Company, Inc., manufacturer of Raws for Paws Ground Turkey Food for Pets, recalled all lots of Raws for Paws Ground Turkey Food for Pets that were manufactured on October 12, 2017.
The recalled product is packaged into 1-pound and 5-pound sealed plastic tubes, also known as chubs. The chubs are packaged into regular Turkey Pet Food cases with case codes of 9900008, 9900009. They are also packaged into Pet Food Combo Pack cases, which contain a variety of pet food products, with case codes 9900014 and 9900015.
The recalled lot codes and the manufacturing dates are printed on the cardboard case label. However, they are not printed on the individual plastic chub packaging. Therefore, if the cardboard case has been discarded, there are no unique identification numbers on the individual chubs that allow customers to determine that they possess the recalled products.
If you purchased this product since October 12, 2017 and cannot determine whether it is affected by the recall, the FDA recommends that you exercise caution and throw the product away.
Christofersen Meats Company, Inc. initiated the recall of the product lots by notifying customers directly. The product is sold online through direct-to-consumer sales via www.rawsforpaws.com . On February 8, 2018, Christofersen Meats Company, Inc. also issued a press release announcing the recall.
The FDA is working with the Minnesota Department of Agriculture to trace back the Ground Turkey Food for Pets to identify the source of the pathogen, where the product was distributed, and to learn more about the potential route of contamination.
This outbreak is of particular public health importance because of the potential hazard to both human and animal health. Pets can get sick from Salmonella, but may also be carriers of the bacteria and can infect humans. Pets do not have to be apparently ill to be able to pass Salmonella onto their human companions.
Raw pet food is more likely than other types of pet food to contain Salmonella and Listeria monocytogenes. Pet owners who choose to feed raw pet food should be aware of the risks associated with these products.
The FDA has a zero-tolerance policy for Salmonella or other pathogenic bacteria in all pet food, meaning the agency will take action, as appropriate, against any commercially-made pet food found to be contaminated with the harmful bacteria.
What are the Symptoms of Salmonella Infection?
Most people infected with Salmonella develop diarrhea, fever and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment.
Pets do not always display symptoms when infected with Salmonella, but signs can include vomiting, diarrhea (which may be bloody), fever, loss of appetite and/or decreased activity level. Pets can transmit Salmonella to humans without showing any signs of the illness themselves.
How Soon After Exposure do Symptoms Appear?
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection.
Although not all pets display symptoms when infected, those who do may have symptoms within 72 hours of infection. Pets do not need to display symptoms to be able to pass Salmonella onto their human companions.
What are the Complications of Salmonella Infections?
In some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Who is at Risk?
Young children are particularly at risk for salmonellosis if they handle or ingest contaminated pet food or unwashed bowls used to feed the pet food. Very young children may also be exposed by crawling on or otherwise touching contaminated surfaces and put their hands or other objects in their mouth (without handwashing), or have oral contact with an animal that has consumed contaminated pet food, or with that animal’s feces. Others at increased risk of serious infection are the elderly, pregnant women, and people with weakened immune systems.
What Do Retailers Need To Do?
Retailers, distributors and other operators who have offered the recalled products for sale should wash and sanitize display cases and refrigerators where potentially contaminated products were stored.
What Do Consumers Need To Do?
Consumers should not feed their pets recalled lots of Raws for Paws Ground Turkey Food for Pets raw pet food from Christofersen Meats Co, Inc. Consumers who purchased this raw pet food should throw it away. People who think they might have become ill or their pets may be ill from exposure to contaminated raw pet food should talk to their health care providers or veterinarians.
Consumers who had this product in their homes should clean their refrigerator and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, toys, floors, and any other surfaces that the food or pet may have had contact with.
Who Should be Contacted?
People who think they might have become ill due to exposure to contaminated raw pet food or the feces of pets that have eaten contaminated raw pet food should talk to their health care providers.
Contact your healthcare provider if you have diarrhea that lasts for more than three days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.
People who think their pets have become ill after consuming contaminated raw pet food should contact their veterinarians. Veterinarians who wish to have dogs tested for Salmonella may do so through the Vet-LIRN Network if the pet is from a household with a person infected with Salmonella.
The FDA encourages consumers to report complaints about this and other pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.
The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.
Additional Information
FDA's Advice: Know the Risks of Feeding Raw Foods to Your Pets
Get the Facts! Raw Pet Food Diets can be Dangerous to You and Your Pet
Avoid the Dangers of Raw Pet Food
CDC Salmonella
---------
FDA Page For This Announcement:
https://www.fda.gov/AnimalVeterinary/Ne ... 596071.htm
FDA Investigates Outbreak of Salmonella Infections Linked to Raws for Paws Ground Turkey Food for Pets
February 9, 2018 -
The U.S. Food and Drug Administration, along with the Minnesota Department of Agriculture and Minnesota Department of Health, is investigating two Salmonella Reading illnesses in Minnesota that are linked to Raws for Paws Ground Turkey Food for Pets.
* The FDA advises consumers not to feed pets certain lots of Raws For Paws Ground Turkey Food for Pets because the product may be contaminated with Salmonella, the presence of which has the potential to cause salmonellosis in humans and animals. The product is sold online by Christofersen Meats Company, Inc., dba Swanson Meats, in Minneapolis, MN (no relation to Swanson Meals).
* The Minnesota Department of Health reports that two children in a single household became sick from Salmonella Reading (S. Reading).
* Testing performed by the Minnesota Department of Health and the Minnesota Department of Agriculture demonstrated that the same strain of S. Reading found in the ill children was also found in four samples of Raws for Paws Ground Turkey Food for Pets that was used to feed the family dog.
* Christofersen Meats Company, Inc. recalled the Raws for Paws product on February 5, 2018 and began directly notifying its customers on the same day.
* This outbreak is of particular public health importance because of the potential hazard to both human and animal health.
What is the Problem and What is Being Done About It?
The U.S. Food and Drug Administration, along with the Minnesota Department of Agriculture and Minnesota Department of Health, is investigating two Salmonella Reading (S. Reading) illnesses in Minnesota that are linked to all lots of Raws for Paws Ground Turkey Food for Pets manufactured on October 12, 2017.
The Minnesota Department of Health reports that two children in a single household were exposed to contaminated Raws for Paws product, which was used to feed the family dog. One child’s illness resulted in septicemia (blood infection) and osteomyelitis, a painful and serious bone infection.
Testing performed by the Minnesota Department of Health and the Minnesota Department of Agriculture demonstrated that the same strain of S. Reading found in the ill children was also found in four samples of Raws for Paws Ground Turkey Food for Pets that was used to feed the family pet.
On February 5, 2018, Christofersen Meats Company, Inc., manufacturer of Raws for Paws Ground Turkey Food for Pets, recalled all lots of Raws for Paws Ground Turkey Food for Pets that were manufactured on October 12, 2017.
The recalled product is packaged into 1-pound and 5-pound sealed plastic tubes, also known as chubs. The chubs are packaged into regular Turkey Pet Food cases with case codes of 9900008, 9900009. They are also packaged into Pet Food Combo Pack cases, which contain a variety of pet food products, with case codes 9900014 and 9900015.
The recalled lot codes and the manufacturing dates are printed on the cardboard case label. However, they are not printed on the individual plastic chub packaging. Therefore, if the cardboard case has been discarded, there are no unique identification numbers on the individual chubs that allow customers to determine that they possess the recalled products.
If you purchased this product since October 12, 2017 and cannot determine whether it is affected by the recall, the FDA recommends that you exercise caution and throw the product away.
Christofersen Meats Company, Inc. initiated the recall of the product lots by notifying customers directly. The product is sold online through direct-to-consumer sales via www.rawsforpaws.com . On February 8, 2018, Christofersen Meats Company, Inc. also issued a press release announcing the recall.
The FDA is working with the Minnesota Department of Agriculture to trace back the Ground Turkey Food for Pets to identify the source of the pathogen, where the product was distributed, and to learn more about the potential route of contamination.
This outbreak is of particular public health importance because of the potential hazard to both human and animal health. Pets can get sick from Salmonella, but may also be carriers of the bacteria and can infect humans. Pets do not have to be apparently ill to be able to pass Salmonella onto their human companions.
Raw pet food is more likely than other types of pet food to contain Salmonella and Listeria monocytogenes. Pet owners who choose to feed raw pet food should be aware of the risks associated with these products.
The FDA has a zero-tolerance policy for Salmonella or other pathogenic bacteria in all pet food, meaning the agency will take action, as appropriate, against any commercially-made pet food found to be contaminated with the harmful bacteria.
What are the Symptoms of Salmonella Infection?
Most people infected with Salmonella develop diarrhea, fever and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment.
Pets do not always display symptoms when infected with Salmonella, but signs can include vomiting, diarrhea (which may be bloody), fever, loss of appetite and/or decreased activity level. Pets can transmit Salmonella to humans without showing any signs of the illness themselves.
How Soon After Exposure do Symptoms Appear?
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection.
Although not all pets display symptoms when infected, those who do may have symptoms within 72 hours of infection. Pets do not need to display symptoms to be able to pass Salmonella onto their human companions.
What are the Complications of Salmonella Infections?
In some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Who is at Risk?
Young children are particularly at risk for salmonellosis if they handle or ingest contaminated pet food or unwashed bowls used to feed the pet food. Very young children may also be exposed by crawling on or otherwise touching contaminated surfaces and put their hands or other objects in their mouth (without handwashing), or have oral contact with an animal that has consumed contaminated pet food, or with that animal’s feces. Others at increased risk of serious infection are the elderly, pregnant women, and people with weakened immune systems.
What Do Retailers Need To Do?
Retailers, distributors and other operators who have offered the recalled products for sale should wash and sanitize display cases and refrigerators where potentially contaminated products were stored.
What Do Consumers Need To Do?
Consumers should not feed their pets recalled lots of Raws for Paws Ground Turkey Food for Pets raw pet food from Christofersen Meats Co, Inc. Consumers who purchased this raw pet food should throw it away. People who think they might have become ill or their pets may be ill from exposure to contaminated raw pet food should talk to their health care providers or veterinarians.
Consumers who had this product in their homes should clean their refrigerator and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, toys, floors, and any other surfaces that the food or pet may have had contact with.
Who Should be Contacted?
People who think they might have become ill due to exposure to contaminated raw pet food or the feces of pets that have eaten contaminated raw pet food should talk to their health care providers.
Contact your healthcare provider if you have diarrhea that lasts for more than three days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.
People who think their pets have become ill after consuming contaminated raw pet food should contact their veterinarians. Veterinarians who wish to have dogs tested for Salmonella may do so through the Vet-LIRN Network if the pet is from a household with a person infected with Salmonella.
The FDA encourages consumers to report complaints about this and other pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.
The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.
Additional Information
FDA's Advice: Know the Risks of Feeding Raw Foods to Your Pets
Get the Facts! Raw Pet Food Diets can be Dangerous to You and Your Pet
Avoid the Dangers of Raw Pet Food
CDC Salmonella
---------
FDA Page For This Announcement:
https://www.fda.gov/AnimalVeterinary/Ne ... 596071.htm
..........Traci
ADMIN NOTE: PLEASE READ POST CAREFULLY, SALMONELLA AND LISTERIA CAN BE DEADLY TO BOTH PETS AND HUMANS!
FDA Investigates Pattern of Contamination in Certain Raw Pet Foods Made by Arrow Reliance Inc., Including Darwin’s Natural Pet Products and ZooLogics Pet Food - This Includes Dog AND Cat Foods.
February 13, 2018 -
The U.S. Food and Drug Administration, along with Washington Department of Agriculture, is investigating a pattern of Salmonella and Listeria monocytogenes contamination in raw pet foods manufactured by Arrow Reliance Inc.
The FDA is alerting pet owners to a history of four recalls of and multiple complaints associated with Darwin’s Natural and ZooLogics pet foods, manufactured by Arrow Reliance Inc., dba Darwin’s Natural Pet Products, over the period from October 17, 2016 to February 10, 2018. In each instance, the company recalled these products after being alerted to positive findings of Salmonella and/or Listeria monocytogenes in samples of their raw pet food products.
In its most recent recall, on February 10, 2018, Arrow Reliance/Darwin’s Natural recalled ZooLogics Duck with Vegetable Meals for Dogs (Lot #41957) and ZooLogics Chicken with Vegetable Meals for Dogs (Lot #41567) because the products may be contaminated with Salmonella and therefore have the potential to cause salmonellosis in humans and animals. The company states that it only sells its products online through direct-to-consumer sales.
The FDA has investigated six complaints of illness and death in animals that have eaten the recalled products.
Arrow Reliance/Darwin’s Natural has notified its customers directly of the recalls, but has so far not issued any public notification announcing this or any of the previous recalls.
This issue is of particular public health importance because Salmonella can make both people and animals sick.
What is the Problem and What is Being Done About It?
As part of an ongoing investigation into complaints associated with products manufactured by Arrow Reliance/Darwin’s Natural of Tukwila, WA, the FDA has confirmed that new samples of Darwin’s Natural Pet Products raw pet foods have tested positive for Salmonella. These raw pet foods include ZooLogics Duck with Vegetable Meals for Dogs Lot #41957 and ZooLogics Chicken with Vegetable Meals for Dogs Lot #41567.
The latest recall was triggered by a complaint of an adult dog that had recurring diarrhea over a nine-month period. The dog tested positive for Salmonella from initial testing by the veterinarian and by follow-up testing by the FDA’s Veterinary Laboratory Investigation and Response Network (Vet-LIRN). The Darwin’s Natural raw pet food that the dog had been fed was also positive for Salmonella.
Arrow Reliance/Darwin’s Natural is aware of the dog's illness and the positive results and initiated a recall on February 10, 2018 by directly notifying its customers via email. The firm has not issued a public recall notice.
Since October 2016, Arrow Reliance/Darwin’s Natural has initiated four recalls and had six reported complaints (some referring to more than one animal) associated with their raw pet food products, including the death of one kitten from a severe systemic Salmonella infection. The Salmonella isolated from the kitten was analyzed using whole genome sequencing and found to be indistinguishable from the Salmonella isolated from a closed package from the same lot of Darwin’s Natural cat food that the kitten ate.
In addition to reports of illnesses associated with Salmonella contamination in the products, the FDA is aware of complaints of at least three animals who were reportedly injured by bone shards in the Darwin’s Natural raw pet food products.
Since 2016, Arrow Reliance/Darwin’s Natural has recalled the following raw pet food products (DOG AND CAT FOODS):
Darwin’s Natural Selections Duck with Organic Vegetables Meals for dogs, due to Salmonella
Lot #40487, manufacture date 9/29/17, in 2 lb. flexible film packages, recalled on 12/04/17
Darwin’s Natural Selections Chicken with Organic Vegetables Meals for Dogs, due to Salmonella and Listeria Monocytogenes
Lot #40727, manufacture date 9/26/17, in 2 lb. flexible film packages, recalled on 12/04/17
Darwin’s Natural Selections Turkey with Organic Vegetables Meals for Dogs, due to Salmonella
Lot #39937, manufacture date 8/24/17 and Lot #40507, manufacture date 9/20/17, in 2 lb. flexible film packages, recalled on 12/04/17
Darwin’s Natural Selections Frozen Duck Meals for Cats, due to potential contamination with Salmonella
Lot #38277, manufacture date 6/1/17, in 2 lb. flexible film packages, recalled on 09/08/17
Darwin’s Natural Selections Frozen Raw Beef with Organic Vegetables Meals for Dogs, due Listeria Monocytogenes
Lot #3146070, manufacture date 7/21/16, in 2 lb. flexible film packages, recalled on 10/17/16
Darwin’s Natural Selections Frozen Raw Turkey with Organic Vegetables Meals for Dogs, due to Listeria Monocytogenes
Lot #3142070, manufacture date 7/20/16, in 2 lb. flexible film packages, recalled on 10/17/16
ZooLogics Frozen Raw Turkey with Vegetable Meals for Dogs, due to Listeria monocytogenes
Lot #3155070, manufacture date 7/25/16, in 2 lb. flexible film packages, recalled on 10/17/16
The recalled lot codes and the manufacturing dates are printed directly on the flexible film packages.
Arrow Reliance/Darwin’s Natural initiated each recall of the product lots by notifying customers directly via email. The company states that the raw pet foods are only sold online through direct-to-consumer sales.
This contaminated raw pet food is of particular public health importance because of the potential hazard to both human and animal health. Pets can get sick from Salmonella, but may also be carriers of the bacteria and can infect humans. Pets do not have to be apparently ill to be able to pass Salmonella onto their human companions.
Raw pet food is more likely than other types of pet food to contain Salmonella and Listeria monocytogenes. Pet owners who choose to feed raw pet food should be aware of the risks associated with these products.
The FDA has a zero-tolerance policy for Salmonella or other pathogenic bacteria in all pet food, meaning the agency will take action, as appropriate, against any pet food found to be contaminated with the harmful bacteria.
What are the Symptoms of Salmonella Infection (Salmonellosis)?
People infected with Salmonella can develop diarrhea, fever and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment.
Pets do not always display symptoms when infected with Salmonella, but signs can include vomiting, diarrhea (which may be bloody), fever, loss of appetite and/or decreased activity level. Pets can pass Salmonella to humans without showing any signs of the illness themselves.
How Soon After Exposure do Salmonellosis Symptoms Appear?
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 6 to 72 hours after infection.
Although not all pets display symptoms when infected, those who do may have symptoms within 72 hours of infection. Pets do not need to display symptoms to be able to pass Salmonella onto their human companions. Once Salmonella gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
What are the Complications of Salmonellosis?
In some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Who is at Risk of Salmonellosis?
Young children are particularly at risk for salmonellosis if they handle or ingest contaminated pet food or unwashed bowls used to feed the pet food. Very young children may also be exposed by crawling on or otherwise touching contaminated surfaces and put their hands or other objects in their mouth (without handwashing), or have oral contact with an animal that has consumed contaminated pet food, or with that animal’s feces. Once Salmonella gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
Others at increased risk of serious infection are the elderly, pregnant women, and people with weakened immune systems.
As with humans, dogs and cats who are very young, very old, or have health conditions are particularly at risk for developing salmonellosis.
What are the Symptoms of Listeria Monocytogenes Infection (Listeriosis)?
Gastrointestinal symptoms including diarrhea, fever, and muscle aches are symptoms of infection with Listeria monocytogenes.
Listeriosis is not common in pets, and when infected, typical symptoms include diarrhea and vomiting.
Pets can pass Listeria monocytogenes to humans without showing any signs of the illness themselves.
How Soon After Exposure do Listeriosis Symptoms Appear?
Gastroenteritis caused by Listeria monocytogenes has a relatively short incubation period, from a few hours to 2 or 3 days. The severe, invasive form of the illness can have a very long incubation period, estimated to vary from 3 days to 3 months.
Although not all pets display symptoms when infected, those who do may have symptoms within a matter of a few hours, but possibly weeks after infection. Pets do not need to display symptoms to be able to pass Listeria monocytogenes onto their human companions. Once Listeria monocytogenes gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
What are the Complications of Listeriosis?
Listeriosis can be fatal, especially in certain high-risk groups. In addition, when Listeria monocytogenes infects a woman during pregnancy, it can cause miscarriage, stillbirth, premature labor, and serious illness or death in newborns.
In severe cases of listeriosis in pets, symptoms include fever, muscular and respiratory signs, abortion, and death.
Who is at Risk of Listeriosis?
High-risk groups include the elderly, people with weakened immune systems and certain chronic medical conditions (such as cancer), and pregnant women.
Very young children are at risk if exposed to Listeria monocytogenes by crawling on or otherwise touching contaminated surfaces and put their hands or other objects in their mouth (without handwashing), or have oral contact with an animal that has consumed contaminated pet food, or with that animal’s feces. Once Listeria monocytogenes gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
Others at increased risk of serious infection are the elderly, pregnant women, and people with weakened immune systems.
As with humans, dogs and cats who are very young, very old, or have health conditions are at an increased risk for developing listeriosis.
What Do Consumers Need To Do?
Consumers should not feed their pets recalled lots of raw pet food manufactured by Arrow Reliance Inc. Consumers who purchased this raw pet food should throw it away. People who think they might have become ill or their pets may be ill from exposure to contaminated raw pet food should talk to their health care providers or veterinarians.
Consumers who had this product in their homes should clean their refrigerator and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, toys, floors, and any other surfaces that the food or pet may have had contact with. Because animals can shed the bacteria when they have bowel movements, it’s particularly important to clean up the animal’s feces in yards or parks where people or other animals may become exposed.
Pet owners who opt to feed their pets a raw diet should consult FDA’s Tips to Prevent Foodborne Illness from Raw Pet Food.
Who Should be Contacted?
People who think they might have become ill due to exposure to contaminated raw pet food or the feces of pets that have eaten contaminated raw pet food should talk to their health care providers.
Contact your health care provider if you have diarrhea that lasts for more than three days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.
People who think their pets have become ill after consuming contaminated raw pet food should contact their veterinarians. Veterinarians who wish to have dogs tested for Salmonella may do so through the Vet-LIRN Network if the pet is from a household with a person infected with Salmonella.
The FDA encourages consumers to report complaints about this and other pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.
The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.
Additional Information
FDA's Advice: Know the Risks of Feeding Raw Foods to Your Pets
Get the Facts! Raw Pet Food Diets can be Dangerous to You and Your Pet
Avoid the Dangers of Raw Pet Food
CDC Salmonella
CDC Listeria
FDA's Announcement Page for This Issue:
https://www.fda.gov/AnimalVeterinary/Ne ... 596555.htm
FDA Investigates Pattern of Contamination in Certain Raw Pet Foods Made by Arrow Reliance Inc., Including Darwin’s Natural Pet Products and ZooLogics Pet Food - This Includes Dog AND Cat Foods.
February 13, 2018 -
The U.S. Food and Drug Administration, along with Washington Department of Agriculture, is investigating a pattern of Salmonella and Listeria monocytogenes contamination in raw pet foods manufactured by Arrow Reliance Inc.
The FDA is alerting pet owners to a history of four recalls of and multiple complaints associated with Darwin’s Natural and ZooLogics pet foods, manufactured by Arrow Reliance Inc., dba Darwin’s Natural Pet Products, over the period from October 17, 2016 to February 10, 2018. In each instance, the company recalled these products after being alerted to positive findings of Salmonella and/or Listeria monocytogenes in samples of their raw pet food products.
In its most recent recall, on February 10, 2018, Arrow Reliance/Darwin’s Natural recalled ZooLogics Duck with Vegetable Meals for Dogs (Lot #41957) and ZooLogics Chicken with Vegetable Meals for Dogs (Lot #41567) because the products may be contaminated with Salmonella and therefore have the potential to cause salmonellosis in humans and animals. The company states that it only sells its products online through direct-to-consumer sales.
The FDA has investigated six complaints of illness and death in animals that have eaten the recalled products.
Arrow Reliance/Darwin’s Natural has notified its customers directly of the recalls, but has so far not issued any public notification announcing this or any of the previous recalls.
This issue is of particular public health importance because Salmonella can make both people and animals sick.
What is the Problem and What is Being Done About It?
As part of an ongoing investigation into complaints associated with products manufactured by Arrow Reliance/Darwin’s Natural of Tukwila, WA, the FDA has confirmed that new samples of Darwin’s Natural Pet Products raw pet foods have tested positive for Salmonella. These raw pet foods include ZooLogics Duck with Vegetable Meals for Dogs Lot #41957 and ZooLogics Chicken with Vegetable Meals for Dogs Lot #41567.
The latest recall was triggered by a complaint of an adult dog that had recurring diarrhea over a nine-month period. The dog tested positive for Salmonella from initial testing by the veterinarian and by follow-up testing by the FDA’s Veterinary Laboratory Investigation and Response Network (Vet-LIRN). The Darwin’s Natural raw pet food that the dog had been fed was also positive for Salmonella.
Arrow Reliance/Darwin’s Natural is aware of the dog's illness and the positive results and initiated a recall on February 10, 2018 by directly notifying its customers via email. The firm has not issued a public recall notice.
Since October 2016, Arrow Reliance/Darwin’s Natural has initiated four recalls and had six reported complaints (some referring to more than one animal) associated with their raw pet food products, including the death of one kitten from a severe systemic Salmonella infection. The Salmonella isolated from the kitten was analyzed using whole genome sequencing and found to be indistinguishable from the Salmonella isolated from a closed package from the same lot of Darwin’s Natural cat food that the kitten ate.
In addition to reports of illnesses associated with Salmonella contamination in the products, the FDA is aware of complaints of at least three animals who were reportedly injured by bone shards in the Darwin’s Natural raw pet food products.
Since 2016, Arrow Reliance/Darwin’s Natural has recalled the following raw pet food products (DOG AND CAT FOODS):
Darwin’s Natural Selections Duck with Organic Vegetables Meals for dogs, due to Salmonella
Lot #40487, manufacture date 9/29/17, in 2 lb. flexible film packages, recalled on 12/04/17
Darwin’s Natural Selections Chicken with Organic Vegetables Meals for Dogs, due to Salmonella and Listeria Monocytogenes
Lot #40727, manufacture date 9/26/17, in 2 lb. flexible film packages, recalled on 12/04/17
Darwin’s Natural Selections Turkey with Organic Vegetables Meals for Dogs, due to Salmonella
Lot #39937, manufacture date 8/24/17 and Lot #40507, manufacture date 9/20/17, in 2 lb. flexible film packages, recalled on 12/04/17
Darwin’s Natural Selections Frozen Duck Meals for Cats, due to potential contamination with Salmonella
Lot #38277, manufacture date 6/1/17, in 2 lb. flexible film packages, recalled on 09/08/17
Darwin’s Natural Selections Frozen Raw Beef with Organic Vegetables Meals for Dogs, due Listeria Monocytogenes
Lot #3146070, manufacture date 7/21/16, in 2 lb. flexible film packages, recalled on 10/17/16
Darwin’s Natural Selections Frozen Raw Turkey with Organic Vegetables Meals for Dogs, due to Listeria Monocytogenes
Lot #3142070, manufacture date 7/20/16, in 2 lb. flexible film packages, recalled on 10/17/16
ZooLogics Frozen Raw Turkey with Vegetable Meals for Dogs, due to Listeria monocytogenes
Lot #3155070, manufacture date 7/25/16, in 2 lb. flexible film packages, recalled on 10/17/16
The recalled lot codes and the manufacturing dates are printed directly on the flexible film packages.
Arrow Reliance/Darwin’s Natural initiated each recall of the product lots by notifying customers directly via email. The company states that the raw pet foods are only sold online through direct-to-consumer sales.
This contaminated raw pet food is of particular public health importance because of the potential hazard to both human and animal health. Pets can get sick from Salmonella, but may also be carriers of the bacteria and can infect humans. Pets do not have to be apparently ill to be able to pass Salmonella onto their human companions.
Raw pet food is more likely than other types of pet food to contain Salmonella and Listeria monocytogenes. Pet owners who choose to feed raw pet food should be aware of the risks associated with these products.
The FDA has a zero-tolerance policy for Salmonella or other pathogenic bacteria in all pet food, meaning the agency will take action, as appropriate, against any pet food found to be contaminated with the harmful bacteria.
What are the Symptoms of Salmonella Infection (Salmonellosis)?
People infected with Salmonella can develop diarrhea, fever and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment.
Pets do not always display symptoms when infected with Salmonella, but signs can include vomiting, diarrhea (which may be bloody), fever, loss of appetite and/or decreased activity level. Pets can pass Salmonella to humans without showing any signs of the illness themselves.
How Soon After Exposure do Salmonellosis Symptoms Appear?
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 6 to 72 hours after infection.
Although not all pets display symptoms when infected, those who do may have symptoms within 72 hours of infection. Pets do not need to display symptoms to be able to pass Salmonella onto their human companions. Once Salmonella gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
What are the Complications of Salmonellosis?
In some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Who is at Risk of Salmonellosis?
Young children are particularly at risk for salmonellosis if they handle or ingest contaminated pet food or unwashed bowls used to feed the pet food. Very young children may also be exposed by crawling on or otherwise touching contaminated surfaces and put their hands or other objects in their mouth (without handwashing), or have oral contact with an animal that has consumed contaminated pet food, or with that animal’s feces. Once Salmonella gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
Others at increased risk of serious infection are the elderly, pregnant women, and people with weakened immune systems.
As with humans, dogs and cats who are very young, very old, or have health conditions are particularly at risk for developing salmonellosis.
What are the Symptoms of Listeria Monocytogenes Infection (Listeriosis)?
Gastrointestinal symptoms including diarrhea, fever, and muscle aches are symptoms of infection with Listeria monocytogenes.
Listeriosis is not common in pets, and when infected, typical symptoms include diarrhea and vomiting.
Pets can pass Listeria monocytogenes to humans without showing any signs of the illness themselves.
How Soon After Exposure do Listeriosis Symptoms Appear?
Gastroenteritis caused by Listeria monocytogenes has a relatively short incubation period, from a few hours to 2 or 3 days. The severe, invasive form of the illness can have a very long incubation period, estimated to vary from 3 days to 3 months.
Although not all pets display symptoms when infected, those who do may have symptoms within a matter of a few hours, but possibly weeks after infection. Pets do not need to display symptoms to be able to pass Listeria monocytogenes onto their human companions. Once Listeria monocytogenes gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
What are the Complications of Listeriosis?
Listeriosis can be fatal, especially in certain high-risk groups. In addition, when Listeria monocytogenes infects a woman during pregnancy, it can cause miscarriage, stillbirth, premature labor, and serious illness or death in newborns.
In severe cases of listeriosis in pets, symptoms include fever, muscular and respiratory signs, abortion, and death.
Who is at Risk of Listeriosis?
High-risk groups include the elderly, people with weakened immune systems and certain chronic medical conditions (such as cancer), and pregnant women.
Very young children are at risk if exposed to Listeria monocytogenes by crawling on or otherwise touching contaminated surfaces and put their hands or other objects in their mouth (without handwashing), or have oral contact with an animal that has consumed contaminated pet food, or with that animal’s feces. Once Listeria monocytogenes gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
Others at increased risk of serious infection are the elderly, pregnant women, and people with weakened immune systems.
As with humans, dogs and cats who are very young, very old, or have health conditions are at an increased risk for developing listeriosis.
What Do Consumers Need To Do?
Consumers should not feed their pets recalled lots of raw pet food manufactured by Arrow Reliance Inc. Consumers who purchased this raw pet food should throw it away. People who think they might have become ill or their pets may be ill from exposure to contaminated raw pet food should talk to their health care providers or veterinarians.
Consumers who had this product in their homes should clean their refrigerator and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, toys, floors, and any other surfaces that the food or pet may have had contact with. Because animals can shed the bacteria when they have bowel movements, it’s particularly important to clean up the animal’s feces in yards or parks where people or other animals may become exposed.
Pet owners who opt to feed their pets a raw diet should consult FDA’s Tips to Prevent Foodborne Illness from Raw Pet Food.
Who Should be Contacted?
People who think they might have become ill due to exposure to contaminated raw pet food or the feces of pets that have eaten contaminated raw pet food should talk to their health care providers.
Contact your health care provider if you have diarrhea that lasts for more than three days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.
People who think their pets have become ill after consuming contaminated raw pet food should contact their veterinarians. Veterinarians who wish to have dogs tested for Salmonella may do so through the Vet-LIRN Network if the pet is from a household with a person infected with Salmonella.
The FDA encourages consumers to report complaints about this and other pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.
The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.
Additional Information
FDA's Advice: Know the Risks of Feeding Raw Foods to Your Pets
Get the Facts! Raw Pet Food Diets can be Dangerous to You and Your Pet
Avoid the Dangers of Raw Pet Food
CDC Salmonella
CDC Listeria
FDA's Announcement Page for This Issue:
https://www.fda.gov/AnimalVeterinary/Ne ... 596555.htm
..........Traci
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
Radagast Pet Food, Inc. Voluntarily Recalls One Lot of Rad Cat Raw Diet Free-Range Chicken and One Lot of Free-Range Turkey Recipe Because of Possible Health Risk
March 20, 2018-
Radagast Pet Food, Inc. of Portland, OR is recalling one lot of Free-Range Chicken and one lot of Free-Range Turkey Recipe because they have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
This recall includes only the two lots listed below.
Listeria monocytogenes is pathogenic to humans. Healthy people exposed to Listeria monocytogenes should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea, abdominal cramping, fever. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.
Listeria monocytogenes can affect animals eating the product. Animals exposed to Listeria monocytogenes can display symptoms such as: diarrhea, fever, muscular or respiratory signs and anorexia. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
No pet or human illnesses have been reported.
The single lot of Rad Cat Raw Diet Free-Range Chicken Lot 62762, BB Date: 10/19/18, was shipped to distributors in May 2017 in CA, MN, OH, OR, PA, and RI. Product has the following UPC’s:
8oz UPC 8 51536 00103 6
16oz UPC 8 51536 00104 3
24oz UPC 8 51536 00105 0
The single lot of Rad Cat Raw Diet Free-Range Turkey Recipe, Lot 62926, BB Date: 05/03/19, was shipped in December 2017 in CA, CO, FL, GA, NY, OH, OR, RI, TX, and WA and sold through independent pet retail stores. Product has the following UPC’s:
8oz UPC 8 51536 00100 5
16oz UPC 8 51536 00101 2
24oz UPC 8 51536 00102 9
Due to Radagast Pet Food’s commitment to safety and quality, Radagast Pet Food is conducting this voluntary recall. The Rad Cat Raw Diet Chicken Lot 62762 was shipped to Distributors in May 2017 and none of this product is in stock with distributors. Rad Cat Raw Diet Free-Range Turkey Recipe was shipped in December 2017 and some product may still be for sale through retailers.
The Company was notified by the FDA and the Ohio Department of Agriculture after several tubs of multiple varieties of Rad Cat Raw Diet were purchased and tested. All samples tested negative for E. Coli and Salmonella but two tested positive for Listeria Monocytogenes.
Consumers are encouraged to check the lot codes on any Free-Range Chicken with the Rad Cat old label style with lot code on the lid of the container and any lot codes on Rad Cat Free-Range Turkey Recipe with lot codes on the bottom of the container. Any products with these lot codes should be returned to the specialty retailer where purchased for a full refund.
Consumers with questions should contact Radagast Pet Food, Inc. at 503-736-4649 Monday- Friday 9:00am – 5:00pm or contact us through our website at www.RadFood.com.
More information including Product Photos:
https://www.fda.gov/Safety/Recalls/ucm601955.htm
March 20, 2018-
Radagast Pet Food, Inc. of Portland, OR is recalling one lot of Free-Range Chicken and one lot of Free-Range Turkey Recipe because they have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
This recall includes only the two lots listed below.
Listeria monocytogenes is pathogenic to humans. Healthy people exposed to Listeria monocytogenes should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea, abdominal cramping, fever. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.
Listeria monocytogenes can affect animals eating the product. Animals exposed to Listeria monocytogenes can display symptoms such as: diarrhea, fever, muscular or respiratory signs and anorexia. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
No pet or human illnesses have been reported.
The single lot of Rad Cat Raw Diet Free-Range Chicken Lot 62762, BB Date: 10/19/18, was shipped to distributors in May 2017 in CA, MN, OH, OR, PA, and RI. Product has the following UPC’s:
8oz UPC 8 51536 00103 6
16oz UPC 8 51536 00104 3
24oz UPC 8 51536 00105 0
The single lot of Rad Cat Raw Diet Free-Range Turkey Recipe, Lot 62926, BB Date: 05/03/19, was shipped in December 2017 in CA, CO, FL, GA, NY, OH, OR, RI, TX, and WA and sold through independent pet retail stores. Product has the following UPC’s:
8oz UPC 8 51536 00100 5
16oz UPC 8 51536 00101 2
24oz UPC 8 51536 00102 9
Due to Radagast Pet Food’s commitment to safety and quality, Radagast Pet Food is conducting this voluntary recall. The Rad Cat Raw Diet Chicken Lot 62762 was shipped to Distributors in May 2017 and none of this product is in stock with distributors. Rad Cat Raw Diet Free-Range Turkey Recipe was shipped in December 2017 and some product may still be for sale through retailers.
The Company was notified by the FDA and the Ohio Department of Agriculture after several tubs of multiple varieties of Rad Cat Raw Diet were purchased and tested. All samples tested negative for E. Coli and Salmonella but two tested positive for Listeria Monocytogenes.
Consumers are encouraged to check the lot codes on any Free-Range Chicken with the Rad Cat old label style with lot code on the lid of the container and any lot codes on Rad Cat Free-Range Turkey Recipe with lot codes on the bottom of the container. Any products with these lot codes should be returned to the specialty retailer where purchased for a full refund.
Consumers with questions should contact Radagast Pet Food, Inc. at 503-736-4649 Monday- Friday 9:00am – 5:00pm or contact us through our website at www.RadFood.com.
More information including Product Photos:
https://www.fda.gov/Safety/Recalls/ucm601955.htm
..........Traci
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
UPDATED: FDA Investigates Pattern of Contamination in Certain Raw Pet Foods Made by Arrow Reliance Inc., Including Darwin’s Natural Pet Products and ZooLogics Pet Food - (this includes dog AND cat food)
Update: March 26, 2018
The FDA has detected Shiga toxin-producing Escherichia coli (STEC) O128 and Salmonella in samples of raw pet foods manufactured by Arrow Reliance Inc. The samples were collected by the FDA to determine whether the firm had addressed an ongoing pattern of pathogenic contamination in Darwin’s and ZooLogics raw pet foods.The firm has recalled the affected products.
The FDA is alerting pet owners to a history of five recalls of and multiple complaints associated with Darwin’s Natural Selections and Darwin's ZooLogics pet foods, manufactured by Arrow Reliance Inc., dba Darwin’s Natural Pet Products, over the period from October 17, 2016 to March 26, 2018. In each instance, the company recalled these products after being alerted to positive findings of Shiga toxin-producing E. coli O128, Salmonella and/or Listeria monocytogenes in samples of their raw pet food products.
In its most recent recall, on March 26, 2018, Arrow Reliance/Darwin’s Natural recalled ZooLogics Chicken with Vegetable Meals for Dogs (Lot #43887 and 44037), ZooLogics Turkey with Vegetable Meals for Dogs (Lot #44127), and ZooLogics Duck with Organic Vegetables Meals for Dogs (Lot # 44147) after FDA found that the products tested positive for Salmonella and/or Shiga toxin-producing E. coli. These products have the potential to cause illness and death in humans and animals. The company states that it only sells its products online through direct-to-consumer sales.
Although there are no reports of illnesses currently identified in connection with the most recent recall on March 26, 2018, the FDA has investigated six complaints of illness and/or death in animals that have eaten previously recalled Darwin’s Natural Selections and/or Darwin’s ZooLogics products.
Arrow Reliance/Darwin’s Natural has notified its customers directly of the recalls.
This issue is of particular public health importance because Salmonella and Listeria monocytogenes can make both people and animals sick, and Shiga toxin-producing E. coli O128 can cause serious illness in humans.
What is the Problem and What is Being Done About It?
As part of an ongoing investigation into complaints associated with products manufactured by Arrow Reliance/Darwin’s Natural of Tukwila, WA, the FDA announced on February 13, 2018, that samples of Darwin’s Natural Pet Products raw pet foods tested positive for Salmonella. These raw pet foods included ZooLogics Duck with Vegetable Meals for Dogs Lot #41957 and ZooLogics Chicken with Vegetable Meals for Dogs Lot #41567.
The February 2018 recall was triggered by a complaint of an adult dog that had recurring diarrhea over a nine-month period. The dog tested positive for Salmonella from initial testing by the veterinarian and by follow-up testing by the FDA’s Veterinary Laboratory Investigation and Response Network (Vet-LIRN). The Darwin’s Natural raw pet food that the dog had been fed was also positive for Salmonella.
Arrow Reliance/Darwin’s Natural was aware of the dog's illness and the positive results and initiated a recall on February 10, 2018 by directly notifying its customers via email. The firm did not issue a public recall notice.
On March 26, 2018, Arrow Reliance/Darwin’s Natural recalled ZooLogics Chicken with Vegetable Meals for Dogs (Lot #43887 and 44037), ZooLogics Turkey with Vegetable Meals for Dogs (Lot #44127), and ZooLogics Duck with Organic Vegetables meals for Dogs (Lot #44147) after FDA testing indicated that the products contained Salmonella and/or Shiga toxin-producing E. coli. These products have the potential to cause illness and death in humans and animals.
Since October 2016, Arrow Reliance/Darwin’s Natural has initiated five recalls and had six reported complaints (some referring to more than one animal) associated with their raw pet food products, including the death of one kitten from a severe systemic Salmonella infection. The Salmonella isolated from the kitten was analyzed using whole genome sequencing and found to be indistinguishable from the Salmonella isolated from a closed package from the same lot of Darwin’s Natural cat food that the kitten ate.
In addition to reports of illnesses associated with Salmonella contamination in the products, the FDA is aware of complaints of at least three animals who were reportedly injured by bone shards in the Darwin’s Natural raw pet food products.
Since 2016, Arrow Reliance/Darwin’s Natural has recalled the following raw pet food products:
ZooLogics Turkey Meals for Dogs, due to Salmonella and Shiga toxin-producing E. coli 0128
Lot #44127, manufacture date 02/04/18, in 2 lb. flexible film packages, recalled on 3/26/2018
Natural Selections Chicken with Organic Vegetables Meals for Dogs, due to Salmonella
Lot #43887, manufacture date 1/30/18, in 2 lb. flexible film packages, recalled on 3/26/2018
ZooLogics Chicken with Vegetables Meals for Dogs, due to Salmonella
Lot #4403743887, manufacture date 2/7/18, in 2 lb. flexible film packages, recalled on 3/26/2018
Natural Selections Duck with Organic Vegetables Meals for Dogs, due to Salmonella
Lot #44147, manufacture date 2/5/18, in 2 lb. flexible film packages, recalled on 3/26/2018
ZooLogics Duck with Vegetable Meals for Dogs, due to Salmonella
Lot #41957, manufacture date 11/16/17, in 2 lb. flexible film packages, recalled on 2/10/18
ZooLogics Chicken with Vegetable Meals for Dogs, due to Salmonella
Lot #41567, manufacture date 11/2/17, in 2 lb. flexible film packages, recalled on 2/10/18
Natural Selections Duck with Organic Vegetables Meals for dogs, due to Salmonella
Lot #40487, manufacture date 9/29/17, in 2 lb. flexible film packages, recalled on 12/04/17
Natural Selections Chicken with Organic Vegetables Meals for Dogs, due to Salmonella and Listeria Monocytogenes
Lot #40727, manufacture date 9/26/17, in 2 lb. flexible film packages, recalled on 12/04/17
Natural Selections Turkey with Organic Vegetables Meals for Dogs, due to Salmonella
Lot #39937, manufacture date 8/24/17 and Lot #40507, manufacture date 9/20/17, in 2 lb. flexible film packages, recalled on 12/04/17
Natural Selections Duck Meals for Cats, due to potential contamination with Salmonella
Lot #38277, manufacture date 6/1/17, in 2 lb. flexible film packages, recalled on 09/08/17
Natural Selections Beef with Organic Vegetables Meals for Dogs, due Listeria Monocytogenes
Lot #3146070, manufacture date 7/21/16, in 2 lb. flexible film packages, recalled on 10/17/16
Natural Selections Turkey with Organic Vegetables Meals for Dogs, due to Listeria Monocytogenes
Lot #3142070, manufacture date 7/20/16, in 2 lb. flexible film packages, recalled on 10/17/16
ZooLogics Turkey with Vegetable Meals for Dogs, due to Listeria monocytogenes
Lot #3155070, manufacture date 7/25/16, in 2 lb. flexible film packages, recalled on 10/17/16
The recalled lot codes and the manufacturing dates are printed directly on the flexible film packages.
Arrow Reliance/Darwin’s Natural initiated each recall of the product lots by notifying customers directly via email. The company states that the raw pet foods are only sold online through direct-to-consumer sales.
This contaminated raw pet food is of particular public health importance because of the potential hazard to both human and animal health. Pets can get sick from Salmonella, Listeria monocytogenes, and E. coli O128, but may also be carriers of the bacteria and can infect humans. Pets do not have to be apparently ill to be able to pass Salmonella, Listeria monocytogenes, and E.coli O128 onto their human companions.
Raw pet food is more likely than other types of pet food to contain Salmonella, Listeria monocytogenes, and E. coli O128. Pet owners who choose to feed raw pet food should be aware of the risks associated with these products.
The FDA has a zero-tolerance policy for Salmonella or other pathogenic bacteria in all pet food, meaning the agency will take action, as appropriate, against any pet food found to be contaminated with the harmful bacteria.
What are the Symptoms of Salmonella Infection (Salmonellosis)?
People infected with Salmonella can develop diarrhea, fever and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment.
Pets do not always display symptoms when infected with Salmonella, but signs can include vomiting, diarrhea (which may be bloody), fever, loss of appetite and/or decreased activity level. Pets can pass Salmonella to humans without showing any signs of the illness themselves.
How Soon After Exposure do Salmonellosis Symptoms Appear?
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 6 to 72 hours after infection.
Although not all pets display symptoms when infected, those who do may have symptoms within 72 hours of infection. Pets do not need to display symptoms to be able to pass Salmonella onto their human companions. Once Salmonella gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
What are the Complications of Salmonellosis?
In some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Who is at Risk of Salmonellosis?
Young children are particularly at risk for salmonellosis if they handle or ingest contaminated pet food or unwashed bowls used to feed the pet food. Very young children may also be exposed by crawling on or otherwise touching contaminated surfaces and put their hands or other objects in their mouth (without handwashing), or have oral contact with an animal that has consumed contaminated pet food, or with that animal’s feces. Once Salmonella gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
Others at increased risk of serious infection are the elderly, pregnant women, and people with weakened immune systems.
As with humans, dogs and cats who are very young, very old, or have health conditions are particularly at risk for developing salmonellosis.
What are the Symptoms of Listeria Monocytogenes Infection (Listeriosis)?
Gastrointestinal symptoms including diarrhea, fever, and muscle aches are symptoms of infection with Listeria monocytogenes.
Listeriosis is not common in pets, and when infected, typical symptoms include diarrhea and vomiting.
Pets can pass Listeria monocytogenes to humans without showing any signs of the illness themselves.
How Soon After Exposure do Listeriosis Symptoms Appear?
Gastroenteritis caused by Listeria monocytogenes has a relatively short incubation period, from a few hours to 2 or 3 days. The severe, invasive form of the illness can have a very long incubation period, estimated to vary from 3 days to 3 months.
Although not all pets display symptoms when infected, those who do may have symptoms within a matter of a few hours, but possibly weeks after infection. Pets do not need to display symptoms to be able to pass Listeria monocytogenes onto their human companions. Once Listeria monocytogenes gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
What are the Complications of Listeriosis?
Listeriosis can be fatal, especially in certain high-risk groups. In addition, when Listeria monocytogenes infects a woman during pregnancy, it can cause miscarriage, stillbirth, premature labor, and serious illness or death in newborns.
In severe cases of listeriosis in pets, symptoms include fever, muscular and respiratory signs, abortion, and death.
Who is at Risk of Listeriosis?
High-risk groups include the elderly, people with weakened immune systems and certain chronic medical conditions (such as cancer), and pregnant women.
Very young children are at risk if exposed to Listeria monocytogenes by crawling on or otherwise touching contaminated surfaces and put their hands or other objects in their mouth (without handwashing), or have oral contact with an animal that has consumed contaminated pet food, or with that animal’s feces. Once Listeria monocytogenes gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
Others at increased risk of serious infection are the elderly, pregnant women, and people with weakened immune systems.
As with humans, dogs and cats who are very young, very old, or have health conditions are at an increased risk for developing listeriosis.
What are the symptoms of E. coli O128 infection?
Most people infected with E. coli O128 can develop nausea or vomiting, diarrhea (often bloody) and abdominal cramps. Most people recover within a week.
Some illnesses last longer and can be more severe, resulting in a type of kidney failure called hemolytic uremic syndrome (HUS). HUS can occur in people of any age, but is most common in young children under 5 years, older adults, and people with weakened immune systems.
Symptoms of HUS can include fever, abdominal pain, pale skin tone, fatigue and irritability, small, unexplained bruises or bleeding from the nose and mouth, and decreased urination. The condition can lead to serious kidney damage and death.
People who experience these symptoms should seek emergency medical care immediately.
Currently, there is no evidence that E. coli O128 causes illness in pets, but pets can serve as carriers and pass E. coli O128 to humans.
How Soon After Exposure do E. coli O128 infection symptoms appear?
People usually get sick from E. coli O128 about 2-8 days (average of 3-4 days) after exposure to the contaminated product.
Pets do not need to display symptoms to be able to pass E. coli O128 onto their human companions. Once E. coli O128 gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
What are the Complications of E. coli O128 infection?
Severe cases of E. coli O128 can result in hemolytic uremic syndrome (HUS), a type of kidney failure. The condition can lead to serious kidney damage and death.
Currently, there is no evidence that E. coli O128 causes illness in pets.
Who is at Risk for E. coli O128?
People of any age can become infected and this infection can resulted in hemolytic uremic syndrome (HUS). But young children, the elderly, and people with weak immune systems are more likely than others to develop severe illness and HUS.
What Do Consumers Need To Do?
Consumers should not feed their pets recalled lots of raw pet food manufactured by Arrow Reliance Inc. Consumers who purchased this raw pet food should throw it away. People who think they might have become ill or their pets may be ill from exposure to contaminated raw pet food should talk to their health care providers or veterinarians.
Consumers who had this product in their homes should clean their refrigerator and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, toys, floors, and any other surfaces that the food or pet may have had contact with. Because animals can shed the bacteria when they have bowel movements, it’s particularly important to clean up the animal’s feces in yards or parks where people or other animals may become exposed.
Pet owners who opt to feed their pets a raw diet should consult FDA’s Tips to Prevent Foodborne Illness from Raw Pet Food.
Who Should be Contacted?
People who think they might have become ill due to exposure to contaminated raw pet food or the feces of pets that have eaten contaminated raw pet food should talk to their health care providers.
Contact your health care provider if you have diarrhea that lasts for more than three days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.
People who think their pets have become ill after consuming contaminated raw pet food should contact their veterinarians. Veterinarians who wish to have dogs tested for Salmonella may do so through the Vet-LIRN Network if the pet is from a household with a person infected with Salmonella.
The FDA encourages consumers to report complaints about this and other pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.
Additional Information
FDA's Advice: Know the Risks of Feeding Raw Foods to Your Pets
Get the Facts! Raw Pet Food Diets can be Dangerous to You and Your Pet
Avoid the Dangers of Raw Pet Food
CDC Salmonella
CDC Listeria
CDC Shiga toxin-producing E. coli
The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available:
https://www.fda.gov/AnimalVeterinary/Ne ... 596555.htm
Update: March 26, 2018
The FDA has detected Shiga toxin-producing Escherichia coli (STEC) O128 and Salmonella in samples of raw pet foods manufactured by Arrow Reliance Inc. The samples were collected by the FDA to determine whether the firm had addressed an ongoing pattern of pathogenic contamination in Darwin’s and ZooLogics raw pet foods.The firm has recalled the affected products.
The FDA is alerting pet owners to a history of five recalls of and multiple complaints associated with Darwin’s Natural Selections and Darwin's ZooLogics pet foods, manufactured by Arrow Reliance Inc., dba Darwin’s Natural Pet Products, over the period from October 17, 2016 to March 26, 2018. In each instance, the company recalled these products after being alerted to positive findings of Shiga toxin-producing E. coli O128, Salmonella and/or Listeria monocytogenes in samples of their raw pet food products.
In its most recent recall, on March 26, 2018, Arrow Reliance/Darwin’s Natural recalled ZooLogics Chicken with Vegetable Meals for Dogs (Lot #43887 and 44037), ZooLogics Turkey with Vegetable Meals for Dogs (Lot #44127), and ZooLogics Duck with Organic Vegetables Meals for Dogs (Lot # 44147) after FDA found that the products tested positive for Salmonella and/or Shiga toxin-producing E. coli. These products have the potential to cause illness and death in humans and animals. The company states that it only sells its products online through direct-to-consumer sales.
Although there are no reports of illnesses currently identified in connection with the most recent recall on March 26, 2018, the FDA has investigated six complaints of illness and/or death in animals that have eaten previously recalled Darwin’s Natural Selections and/or Darwin’s ZooLogics products.
Arrow Reliance/Darwin’s Natural has notified its customers directly of the recalls.
This issue is of particular public health importance because Salmonella and Listeria monocytogenes can make both people and animals sick, and Shiga toxin-producing E. coli O128 can cause serious illness in humans.
What is the Problem and What is Being Done About It?
As part of an ongoing investigation into complaints associated with products manufactured by Arrow Reliance/Darwin’s Natural of Tukwila, WA, the FDA announced on February 13, 2018, that samples of Darwin’s Natural Pet Products raw pet foods tested positive for Salmonella. These raw pet foods included ZooLogics Duck with Vegetable Meals for Dogs Lot #41957 and ZooLogics Chicken with Vegetable Meals for Dogs Lot #41567.
The February 2018 recall was triggered by a complaint of an adult dog that had recurring diarrhea over a nine-month period. The dog tested positive for Salmonella from initial testing by the veterinarian and by follow-up testing by the FDA’s Veterinary Laboratory Investigation and Response Network (Vet-LIRN). The Darwin’s Natural raw pet food that the dog had been fed was also positive for Salmonella.
Arrow Reliance/Darwin’s Natural was aware of the dog's illness and the positive results and initiated a recall on February 10, 2018 by directly notifying its customers via email. The firm did not issue a public recall notice.
On March 26, 2018, Arrow Reliance/Darwin’s Natural recalled ZooLogics Chicken with Vegetable Meals for Dogs (Lot #43887 and 44037), ZooLogics Turkey with Vegetable Meals for Dogs (Lot #44127), and ZooLogics Duck with Organic Vegetables meals for Dogs (Lot #44147) after FDA testing indicated that the products contained Salmonella and/or Shiga toxin-producing E. coli. These products have the potential to cause illness and death in humans and animals.
Since October 2016, Arrow Reliance/Darwin’s Natural has initiated five recalls and had six reported complaints (some referring to more than one animal) associated with their raw pet food products, including the death of one kitten from a severe systemic Salmonella infection. The Salmonella isolated from the kitten was analyzed using whole genome sequencing and found to be indistinguishable from the Salmonella isolated from a closed package from the same lot of Darwin’s Natural cat food that the kitten ate.
In addition to reports of illnesses associated with Salmonella contamination in the products, the FDA is aware of complaints of at least three animals who were reportedly injured by bone shards in the Darwin’s Natural raw pet food products.
Since 2016, Arrow Reliance/Darwin’s Natural has recalled the following raw pet food products:
ZooLogics Turkey Meals for Dogs, due to Salmonella and Shiga toxin-producing E. coli 0128
Lot #44127, manufacture date 02/04/18, in 2 lb. flexible film packages, recalled on 3/26/2018
Natural Selections Chicken with Organic Vegetables Meals for Dogs, due to Salmonella
Lot #43887, manufacture date 1/30/18, in 2 lb. flexible film packages, recalled on 3/26/2018
ZooLogics Chicken with Vegetables Meals for Dogs, due to Salmonella
Lot #4403743887, manufacture date 2/7/18, in 2 lb. flexible film packages, recalled on 3/26/2018
Natural Selections Duck with Organic Vegetables Meals for Dogs, due to Salmonella
Lot #44147, manufacture date 2/5/18, in 2 lb. flexible film packages, recalled on 3/26/2018
ZooLogics Duck with Vegetable Meals for Dogs, due to Salmonella
Lot #41957, manufacture date 11/16/17, in 2 lb. flexible film packages, recalled on 2/10/18
ZooLogics Chicken with Vegetable Meals for Dogs, due to Salmonella
Lot #41567, manufacture date 11/2/17, in 2 lb. flexible film packages, recalled on 2/10/18
Natural Selections Duck with Organic Vegetables Meals for dogs, due to Salmonella
Lot #40487, manufacture date 9/29/17, in 2 lb. flexible film packages, recalled on 12/04/17
Natural Selections Chicken with Organic Vegetables Meals for Dogs, due to Salmonella and Listeria Monocytogenes
Lot #40727, manufacture date 9/26/17, in 2 lb. flexible film packages, recalled on 12/04/17
Natural Selections Turkey with Organic Vegetables Meals for Dogs, due to Salmonella
Lot #39937, manufacture date 8/24/17 and Lot #40507, manufacture date 9/20/17, in 2 lb. flexible film packages, recalled on 12/04/17
Natural Selections Duck Meals for Cats, due to potential contamination with Salmonella
Lot #38277, manufacture date 6/1/17, in 2 lb. flexible film packages, recalled on 09/08/17
Natural Selections Beef with Organic Vegetables Meals for Dogs, due Listeria Monocytogenes
Lot #3146070, manufacture date 7/21/16, in 2 lb. flexible film packages, recalled on 10/17/16
Natural Selections Turkey with Organic Vegetables Meals for Dogs, due to Listeria Monocytogenes
Lot #3142070, manufacture date 7/20/16, in 2 lb. flexible film packages, recalled on 10/17/16
ZooLogics Turkey with Vegetable Meals for Dogs, due to Listeria monocytogenes
Lot #3155070, manufacture date 7/25/16, in 2 lb. flexible film packages, recalled on 10/17/16
The recalled lot codes and the manufacturing dates are printed directly on the flexible film packages.
Arrow Reliance/Darwin’s Natural initiated each recall of the product lots by notifying customers directly via email. The company states that the raw pet foods are only sold online through direct-to-consumer sales.
This contaminated raw pet food is of particular public health importance because of the potential hazard to both human and animal health. Pets can get sick from Salmonella, Listeria monocytogenes, and E. coli O128, but may also be carriers of the bacteria and can infect humans. Pets do not have to be apparently ill to be able to pass Salmonella, Listeria monocytogenes, and E.coli O128 onto their human companions.
Raw pet food is more likely than other types of pet food to contain Salmonella, Listeria monocytogenes, and E. coli O128. Pet owners who choose to feed raw pet food should be aware of the risks associated with these products.
The FDA has a zero-tolerance policy for Salmonella or other pathogenic bacteria in all pet food, meaning the agency will take action, as appropriate, against any pet food found to be contaminated with the harmful bacteria.
What are the Symptoms of Salmonella Infection (Salmonellosis)?
People infected with Salmonella can develop diarrhea, fever and abdominal cramps. The illness usually lasts 4 to 7 days, and most people recover without treatment.
Pets do not always display symptoms when infected with Salmonella, but signs can include vomiting, diarrhea (which may be bloody), fever, loss of appetite and/or decreased activity level. Pets can pass Salmonella to humans without showing any signs of the illness themselves.
How Soon After Exposure do Salmonellosis Symptoms Appear?
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 6 to 72 hours after infection.
Although not all pets display symptoms when infected, those who do may have symptoms within 72 hours of infection. Pets do not need to display symptoms to be able to pass Salmonella onto their human companions. Once Salmonella gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
What are the Complications of Salmonellosis?
In some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Who is at Risk of Salmonellosis?
Young children are particularly at risk for salmonellosis if they handle or ingest contaminated pet food or unwashed bowls used to feed the pet food. Very young children may also be exposed by crawling on or otherwise touching contaminated surfaces and put their hands or other objects in their mouth (without handwashing), or have oral contact with an animal that has consumed contaminated pet food, or with that animal’s feces. Once Salmonella gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
Others at increased risk of serious infection are the elderly, pregnant women, and people with weakened immune systems.
As with humans, dogs and cats who are very young, very old, or have health conditions are particularly at risk for developing salmonellosis.
What are the Symptoms of Listeria Monocytogenes Infection (Listeriosis)?
Gastrointestinal symptoms including diarrhea, fever, and muscle aches are symptoms of infection with Listeria monocytogenes.
Listeriosis is not common in pets, and when infected, typical symptoms include diarrhea and vomiting.
Pets can pass Listeria monocytogenes to humans without showing any signs of the illness themselves.
How Soon After Exposure do Listeriosis Symptoms Appear?
Gastroenteritis caused by Listeria monocytogenes has a relatively short incubation period, from a few hours to 2 or 3 days. The severe, invasive form of the illness can have a very long incubation period, estimated to vary from 3 days to 3 months.
Although not all pets display symptoms when infected, those who do may have symptoms within a matter of a few hours, but possibly weeks after infection. Pets do not need to display symptoms to be able to pass Listeria monocytogenes onto their human companions. Once Listeria monocytogenes gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
What are the Complications of Listeriosis?
Listeriosis can be fatal, especially in certain high-risk groups. In addition, when Listeria monocytogenes infects a woman during pregnancy, it can cause miscarriage, stillbirth, premature labor, and serious illness or death in newborns.
In severe cases of listeriosis in pets, symptoms include fever, muscular and respiratory signs, abortion, and death.
Who is at Risk of Listeriosis?
High-risk groups include the elderly, people with weakened immune systems and certain chronic medical conditions (such as cancer), and pregnant women.
Very young children are at risk if exposed to Listeria monocytogenes by crawling on or otherwise touching contaminated surfaces and put their hands or other objects in their mouth (without handwashing), or have oral contact with an animal that has consumed contaminated pet food, or with that animal’s feces. Once Listeria monocytogenes gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
Others at increased risk of serious infection are the elderly, pregnant women, and people with weakened immune systems.
As with humans, dogs and cats who are very young, very old, or have health conditions are at an increased risk for developing listeriosis.
What are the symptoms of E. coli O128 infection?
Most people infected with E. coli O128 can develop nausea or vomiting, diarrhea (often bloody) and abdominal cramps. Most people recover within a week.
Some illnesses last longer and can be more severe, resulting in a type of kidney failure called hemolytic uremic syndrome (HUS). HUS can occur in people of any age, but is most common in young children under 5 years, older adults, and people with weakened immune systems.
Symptoms of HUS can include fever, abdominal pain, pale skin tone, fatigue and irritability, small, unexplained bruises or bleeding from the nose and mouth, and decreased urination. The condition can lead to serious kidney damage and death.
People who experience these symptoms should seek emergency medical care immediately.
Currently, there is no evidence that E. coli O128 causes illness in pets, but pets can serve as carriers and pass E. coli O128 to humans.
How Soon After Exposure do E. coli O128 infection symptoms appear?
People usually get sick from E. coli O128 about 2-8 days (average of 3-4 days) after exposure to the contaminated product.
Pets do not need to display symptoms to be able to pass E. coli O128 onto their human companions. Once E. coli O128 gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread.
What are the Complications of E. coli O128 infection?
Severe cases of E. coli O128 can result in hemolytic uremic syndrome (HUS), a type of kidney failure. The condition can lead to serious kidney damage and death.
Currently, there is no evidence that E. coli O128 causes illness in pets.
Who is at Risk for E. coli O128?
People of any age can become infected and this infection can resulted in hemolytic uremic syndrome (HUS). But young children, the elderly, and people with weak immune systems are more likely than others to develop severe illness and HUS.
What Do Consumers Need To Do?
Consumers should not feed their pets recalled lots of raw pet food manufactured by Arrow Reliance Inc. Consumers who purchased this raw pet food should throw it away. People who think they might have become ill or their pets may be ill from exposure to contaminated raw pet food should talk to their health care providers or veterinarians.
Consumers who had this product in their homes should clean their refrigerator and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, toys, floors, and any other surfaces that the food or pet may have had contact with. Because animals can shed the bacteria when they have bowel movements, it’s particularly important to clean up the animal’s feces in yards or parks where people or other animals may become exposed.
Pet owners who opt to feed their pets a raw diet should consult FDA’s Tips to Prevent Foodborne Illness from Raw Pet Food.
Who Should be Contacted?
People who think they might have become ill due to exposure to contaminated raw pet food or the feces of pets that have eaten contaminated raw pet food should talk to their health care providers.
Contact your health care provider if you have diarrhea that lasts for more than three days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.
People who think their pets have become ill after consuming contaminated raw pet food should contact their veterinarians. Veterinarians who wish to have dogs tested for Salmonella may do so through the Vet-LIRN Network if the pet is from a household with a person infected with Salmonella.
The FDA encourages consumers to report complaints about this and other pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.
Additional Information
FDA's Advice: Know the Risks of Feeding Raw Foods to Your Pets
Get the Facts! Raw Pet Food Diets can be Dangerous to You and Your Pet
Avoid the Dangers of Raw Pet Food
CDC Salmonella
CDC Listeria
CDC Shiga toxin-producing E. coli
The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available:
https://www.fda.gov/AnimalVeterinary/Ne ... 596555.htm
..........Traci
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products
Firm recalls hundreds of water-based products for humans and pets due to microbial contamination
August 28, 2018-
The Food and Drug Administration is warning consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio Inc., Asheville, N.C., and labeled as Dr. King’s, as these products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to high levels of microbial contamination identified at the manufacturing site. King Bio has expanded its voluntary recall for a second time to include all water-based (aqueous) drug products marketed for human and animals. The FDA recommends that consumers stop using and dispose of these products immediately.
“We take product quality issues seriously, and when we see substandard conditions during the course of our inspections – in this case conditions that are leading to high levels of microbial contamination with the potential to harm the public -- we act swiftly to try to ensure the products are removed from circulation,” said FDA Commissioner Scott Gottlieb, M.D. “In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In addition to our concerns with contamination, some homeopathic products may not deliver any benefit and have the potential to cause harm. That’s why we’ve taken steps in the last year to advance a new regulatory approach to prioritize additional enforcement and regulatory actions against certain homeopathic products. We’re focused on products that have the greatest potential to cause risk to patients, including products for vulnerable populations like children. In the past year, we’ve also taken actions against homeopathic products that were making unproven drug claims.”
King Bio manufactures a range of products including those for children, adults and pets. Products that are part of the recall include Dr. King’s Children’s Cough Relief, Dr. King’s Chicken Pox Symptom Relief, Dr. King’s Children’s Ear Relief Formula, Dr. King’s Children’s Appetite Enhancer, Dr. King’s Attention and Learning Enhancement For Kids, Dr. King’s Cold Sore treatment, Dr. King’s Wart Freeze, and pet products for urinary incontinence and digestion relief. The full list of products is listed on the King Bio website , HERE.
Consumers and pets who use these products could have an increased risk of serious infection, that could require medical attention, due to the high levels of microbial contamination. An infection could be a life-threatening event for immunocompromised patients. Consumers and pet owners who have purchased these products should contact their health care professional if they have concerns or observe signs of an infection after use of these products.
The FDA recently inspected King Bio’s facility and collected product samples. The FDA is currently testing and analyzing product samples collected at the facility. According to the company, several microbial contaminants were found in its products, including Burkholderia Multivorans, which is a strain of bacteria called Burkholderia cepacia complex (BCC) that can cause illness in people with compromised immune systems. Additionally, evidence collected during the FDA’s inspection indicates recurring microbial contamination associated with the water system used to manufacture drug products.
King Bio voluntarily recalled three drug products labeled as homeopathic due to confirmed microbial contamination in July 2018. The company then expanded its voluntary recall to include an additional 32 drug products on August 22, 2018. The FDA contacted King Bio on August 23, 2018, and recommended the company again expand its recall to include all products that use water as an ingredient, including drug products for humans and animals. The company is expanding its recall to drug products made with water marketed for human and animals.
Products labeled as homeopathic can contain a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals, and chemicals. These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products, and are sold online and in major retail stores. The FDA has not approved any products labeled as homeopathic; this means that any product labeled as homeopathic is being marketed in the U.S. without FDA evaluation for safety or effectiveness. These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or contain active ingredients that aren’t adequately tested or disclosed to patients, such as belladonna, which the agency has previously warned against.
Because of the increase in the marketing and use of homeopathic products that claim to treat serious diseases and conditions, as well as conditions specific to children and infants, the FDA recently proposed a new, risk-based enforcement approach for products labeled as homeopathic in December 2017. Under the proposed new approach, the agency stated it would intend to focus its enforcement authorities on products that have the potential to cause risk to patients, including those with reported safety concerns, products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions, as well as products for vulnerable populations and others.
In addition to the FDA’s concerns about the company’s recurring issues with contamination, the FDA and the Federal Trade Commission (FTC) issued a joint warning letter to King Bio in January 2018, for illegally marketing an unapproved product to prevent, cure or treat opioid addiction.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of King Bio’s products to the FDA’s MedWatch Adverse Event Reporting program:
* Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
* Download and complete the form, then submit it via fax at 1-800-FDA-0178.
For reporting adverse drug events in animals, please see How to Report Animal Drug Side Effects and Product Problems.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
FDA NEWS RELEASE
https://www.fda.gov/NewsEvents/Newsroom ... 618691.htm
Firm recalls hundreds of water-based products for humans and pets due to microbial contamination
August 28, 2018-
The Food and Drug Administration is warning consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio Inc., Asheville, N.C., and labeled as Dr. King’s, as these products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to high levels of microbial contamination identified at the manufacturing site. King Bio has expanded its voluntary recall for a second time to include all water-based (aqueous) drug products marketed for human and animals. The FDA recommends that consumers stop using and dispose of these products immediately.
“We take product quality issues seriously, and when we see substandard conditions during the course of our inspections – in this case conditions that are leading to high levels of microbial contamination with the potential to harm the public -- we act swiftly to try to ensure the products are removed from circulation,” said FDA Commissioner Scott Gottlieb, M.D. “In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In addition to our concerns with contamination, some homeopathic products may not deliver any benefit and have the potential to cause harm. That’s why we’ve taken steps in the last year to advance a new regulatory approach to prioritize additional enforcement and regulatory actions against certain homeopathic products. We’re focused on products that have the greatest potential to cause risk to patients, including products for vulnerable populations like children. In the past year, we’ve also taken actions against homeopathic products that were making unproven drug claims.”
King Bio manufactures a range of products including those for children, adults and pets. Products that are part of the recall include Dr. King’s Children’s Cough Relief, Dr. King’s Chicken Pox Symptom Relief, Dr. King’s Children’s Ear Relief Formula, Dr. King’s Children’s Appetite Enhancer, Dr. King’s Attention and Learning Enhancement For Kids, Dr. King’s Cold Sore treatment, Dr. King’s Wart Freeze, and pet products for urinary incontinence and digestion relief. The full list of products is listed on the King Bio website , HERE.
Consumers and pets who use these products could have an increased risk of serious infection, that could require medical attention, due to the high levels of microbial contamination. An infection could be a life-threatening event for immunocompromised patients. Consumers and pet owners who have purchased these products should contact their health care professional if they have concerns or observe signs of an infection after use of these products.
The FDA recently inspected King Bio’s facility and collected product samples. The FDA is currently testing and analyzing product samples collected at the facility. According to the company, several microbial contaminants were found in its products, including Burkholderia Multivorans, which is a strain of bacteria called Burkholderia cepacia complex (BCC) that can cause illness in people with compromised immune systems. Additionally, evidence collected during the FDA’s inspection indicates recurring microbial contamination associated with the water system used to manufacture drug products.
King Bio voluntarily recalled three drug products labeled as homeopathic due to confirmed microbial contamination in July 2018. The company then expanded its voluntary recall to include an additional 32 drug products on August 22, 2018. The FDA contacted King Bio on August 23, 2018, and recommended the company again expand its recall to include all products that use water as an ingredient, including drug products for humans and animals. The company is expanding its recall to drug products made with water marketed for human and animals.
Products labeled as homeopathic can contain a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals, and chemicals. These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products, and are sold online and in major retail stores. The FDA has not approved any products labeled as homeopathic; this means that any product labeled as homeopathic is being marketed in the U.S. without FDA evaluation for safety or effectiveness. These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or contain active ingredients that aren’t adequately tested or disclosed to patients, such as belladonna, which the agency has previously warned against.
Because of the increase in the marketing and use of homeopathic products that claim to treat serious diseases and conditions, as well as conditions specific to children and infants, the FDA recently proposed a new, risk-based enforcement approach for products labeled as homeopathic in December 2017. Under the proposed new approach, the agency stated it would intend to focus its enforcement authorities on products that have the potential to cause risk to patients, including those with reported safety concerns, products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions, as well as products for vulnerable populations and others.
In addition to the FDA’s concerns about the company’s recurring issues with contamination, the FDA and the Federal Trade Commission (FTC) issued a joint warning letter to King Bio in January 2018, for illegally marketing an unapproved product to prevent, cure or treat opioid addiction.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of King Bio’s products to the FDA’s MedWatch Adverse Event Reporting program:
* Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
* Download and complete the form, then submit it via fax at 1-800-FDA-0178.
For reporting adverse drug events in animals, please see How to Report Animal Drug Side Effects and Product Problems.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
FDA NEWS RELEASE
https://www.fda.gov/NewsEvents/Newsroom ... 618691.htm
..........Traci
Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD
FDA Cautions Pet Owners Not to Feed One Lot of Hare Today Gone Tomorrow Due to Salmonella and Listeria monocytogenes
January 23, 2019 -
Fast Facts
* The U.S. Food and Drug Administration is cautioning pet owners not to feed Hare Today Gone Tomorrow Ground Chicken/Bones/Organs, lot 12.04.2018, after the product tested positive for Salmonella and Listeria monocytogenes (L. mono). This product is identified as “Ground Chicken” on the product labeling and as “Ground Chicken/Bones/Organs” on the firm’s website.
* If you have this lot of Hare Today Gone Tomorrow Ground Chicken/Bones/Organs, throw it away.
* Salmonella and L. mono can affect both human and animal health. People with symptoms of Salmonella or L. mono infections should consult their health care providers. Consult a veterinarian if your pet has symptoms of Salmonella or L. mono infection.
What is the problem?
The U.S. Food and Drug Administration is cautioning pet owners not to feed Hare Today Gone Tomorrow Ground Chicken/Bones/Organs, lot 12.04.2018, after a sample of the product collected by the FDA tested positive for Salmonella and Listeria monocytogenes (L. mono). The product is available in four sizes and varieties, all with the processing date of 12.04.2018 on the back of the bag:
Ground Chicken/Bones/Organs, 1lb, Fine Ground
Ground Chicken/Bones/Organs, 2lb, Fine Ground
Ground Chicken/Bones/Organs, 3lb, Coarse Ground
Ground Chicken/Bones/Organs, 5lb, Fine Ground
The FDA collected this sample while following up on a consumer complaint in which a kitten became sick with Salmonella after eating the recalled product. The specific lot of Hare Today Gone Tomorrow Ground Chicken/Bones/Organs that the sick kitten ate was not available for testing. The FDA collected samples from lot 12.04.2018, which tested positive for both Salmonella and L. mono. Although the Salmonella isolated from the feces of the sick kitten did not match the strain found in the product sample, Federal law requires that all pet food not be contaminated with pathogens, including Salmonella and L. mono, because of the potential impact on human and animal health.
Why is the FDA issuing this alert?
The FDA is issuing this alert because Hare Today Gone Tomorrow Ground Chicken/Bones/Organs, lot 12.04.2018, represents a serious threat to human and animal health and is adulterated under the Federal Food, Drug, and Cosmetic Act because it contains Salmonella and L. mono. The FDA continues to work with Hare Today Gone Tomorrow on recalling its Ground Chicken/Bones/Organs, lot 12.04.2018.
What do I need to do?
If you have Hare Today Gone Tomorrow Ground Chicken/Bones/Organs, lot 12.04.2018, stop feeding it to your pets and throw it away in a secure container where other animals, including wildlife, cannot access it. Consumers who have had this product in their homes should clean refrigerators/freezers where the product was stored and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, toys, floors, and any other surfaces that the food or pet may have had contact with. Clean up the pet’s feces in yards or parks where people or other animals may become exposed.
What is Salmonella and what are the symptoms of Salmonella infection?
Salmonella is a bacterium that can cause illness and death in humans and animals, especially those who are very young, very old, or have weak immune systems. According to the Centers for Disease Control and Prevention (CDC), people infected with Salmonella can develop diarrhea, fever and abdominal cramps. Most people recover without treatment, but in some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream and then to other body sites unless the person is treated promptly with antibiotics. Consult your health care provider if you have symptoms of Salmonella infection.
Pets do not always display symptoms when infected with Salmonella, but signs can include vomiting, diarrhea (which may be bloody), fever, loss of appetite and/or decreased activity level. If your pet has these symptoms, consult a veterinarian promptly. You should also be aware that infected pets can shed the bacteria in their feces without showing signs of being sick.
What are the symptoms of L. mono infection (listeriosis)?
According to CDC, listeriosis can cause a variety of symptoms, depending on the person and the part of the body affected.
Pregnant women: Pregnant women typically experience only fever and other flu-like symptoms, such as fatigue and muscle aches. However, infections during pregnancy can lead to miscarriage, stillbirth, premature delivery, or life-threatening infection of the newborn.
People other than pregnant women: Symptoms can include headache, stiff neck, confusion, loss of balance, and convulsions in addition to fever and muscle aches.
People with invasive listeriosis, a more serious form of the disease, usually report symptoms starting 1 to 4 weeks after eating food contaminated with Listeria; some people have reported symptoms starting as late as 70 days after exposure or as early as the same day of exposure. Listeriosis is treated with antibiotics.
Pregnant women and their newborns, adults age 65 and older, and people with weakened immune systems are more likely to get sick with listeriosis. Anyone with symptoms of listeriosis should contact a health care provider.
L. mono infections are uncommon in pets, but they are possible. Symptoms may include mild to severe diarrhea; anorexia; fever; nervous, muscular and respiratory signs; abortion; depression; shock; and death. Pets do not need to display symptoms to be able to pass L. mono on to their human companions. Once L. mono gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination may continue to spread. If your pet has these symptoms, consult a veterinarian promptly.
Why is the FDA concerned about Salmonella and L. mono in pet food?
Pet foods contaminated with pathogens such as Salmonella and L. mono are of particular public health importance because they can affect both human and animal health. Pets can get sick from Salmonella and L. mono, and may also be carriers of the bacteria and pass it onto their human companions without appearing to be ill. The FDA is aware of recent cases in which humans and/or animals have gotten sick from exposure to contaminated pet foods (Salmonella-human cases, Salmonella-kitten, Salmonella-kitten, dog).
Once Salmonella and/or L. mono get established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread. Because animals can shed the bacteria when they have bowel movements, it’s particularly important to clean up the animal’s feces in yards or parks where people or other animals may become exposed, in addition to cleaning items in the home.
Federal law, including the Federal Food, Drug, and Cosmetic Act, requires that all pet food not be contaminated with pathogens, including Salmonella and L. mono. Pet food manufacturers must effectively manage sourcing of ingredients, processing and packing to control pathogens. Without an effective control, such as cooking, raw pet food is more likely than other types of pet food to contain pathogens such as Salmonella and L. mono. Refrigeration or freezing does not kill the bacteria. Pet owners who choose to feed raw pet food should be aware of the risks associated with these products.
The FDA is the Federal agency that regulates pet food, while the United States Department of Agriculture (USDA) regulates meat and poultry for human consumption. USDA-regulated raw meat and poultry products are intended to be cooked and carry instructions to cook the product to a safe temperature. However, raw pet food products are intended to be served without further cooking, which creates a potential health hazard for people and pets exposed to the product.
How can I report a pet illness?
People who think their pets have become ill after consuming contaminated pet food should first contact their veterinarians. Veterinarians who wish to have pets tested for Salmonella may do so through the Vet-LIRN Network if the pet is from a household with a person infected with Salmonella. Veterinarians who wish to have pets tested for other pathogens when there is an associated human case may also contact Vet-LIRN.
The FDA encourages consumers to report complaints about this and other pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.
https://www.fda.gov/AnimalVeterinary/Ne ... 629711.htm
January 23, 2019 -
Fast Facts
* The U.S. Food and Drug Administration is cautioning pet owners not to feed Hare Today Gone Tomorrow Ground Chicken/Bones/Organs, lot 12.04.2018, after the product tested positive for Salmonella and Listeria monocytogenes (L. mono). This product is identified as “Ground Chicken” on the product labeling and as “Ground Chicken/Bones/Organs” on the firm’s website.
* If you have this lot of Hare Today Gone Tomorrow Ground Chicken/Bones/Organs, throw it away.
* Salmonella and L. mono can affect both human and animal health. People with symptoms of Salmonella or L. mono infections should consult their health care providers. Consult a veterinarian if your pet has symptoms of Salmonella or L. mono infection.
What is the problem?
The U.S. Food and Drug Administration is cautioning pet owners not to feed Hare Today Gone Tomorrow Ground Chicken/Bones/Organs, lot 12.04.2018, after a sample of the product collected by the FDA tested positive for Salmonella and Listeria monocytogenes (L. mono). The product is available in four sizes and varieties, all with the processing date of 12.04.2018 on the back of the bag:
Ground Chicken/Bones/Organs, 1lb, Fine Ground
Ground Chicken/Bones/Organs, 2lb, Fine Ground
Ground Chicken/Bones/Organs, 3lb, Coarse Ground
Ground Chicken/Bones/Organs, 5lb, Fine Ground
The FDA collected this sample while following up on a consumer complaint in which a kitten became sick with Salmonella after eating the recalled product. The specific lot of Hare Today Gone Tomorrow Ground Chicken/Bones/Organs that the sick kitten ate was not available for testing. The FDA collected samples from lot 12.04.2018, which tested positive for both Salmonella and L. mono. Although the Salmonella isolated from the feces of the sick kitten did not match the strain found in the product sample, Federal law requires that all pet food not be contaminated with pathogens, including Salmonella and L. mono, because of the potential impact on human and animal health.
Why is the FDA issuing this alert?
The FDA is issuing this alert because Hare Today Gone Tomorrow Ground Chicken/Bones/Organs, lot 12.04.2018, represents a serious threat to human and animal health and is adulterated under the Federal Food, Drug, and Cosmetic Act because it contains Salmonella and L. mono. The FDA continues to work with Hare Today Gone Tomorrow on recalling its Ground Chicken/Bones/Organs, lot 12.04.2018.
What do I need to do?
If you have Hare Today Gone Tomorrow Ground Chicken/Bones/Organs, lot 12.04.2018, stop feeding it to your pets and throw it away in a secure container where other animals, including wildlife, cannot access it. Consumers who have had this product in their homes should clean refrigerators/freezers where the product was stored and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, toys, floors, and any other surfaces that the food or pet may have had contact with. Clean up the pet’s feces in yards or parks where people or other animals may become exposed.
What is Salmonella and what are the symptoms of Salmonella infection?
Salmonella is a bacterium that can cause illness and death in humans and animals, especially those who are very young, very old, or have weak immune systems. According to the Centers for Disease Control and Prevention (CDC), people infected with Salmonella can develop diarrhea, fever and abdominal cramps. Most people recover without treatment, but in some people, the diarrhea may be so severe that they need to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream and then to other body sites unless the person is treated promptly with antibiotics. Consult your health care provider if you have symptoms of Salmonella infection.
Pets do not always display symptoms when infected with Salmonella, but signs can include vomiting, diarrhea (which may be bloody), fever, loss of appetite and/or decreased activity level. If your pet has these symptoms, consult a veterinarian promptly. You should also be aware that infected pets can shed the bacteria in their feces without showing signs of being sick.
What are the symptoms of L. mono infection (listeriosis)?
According to CDC, listeriosis can cause a variety of symptoms, depending on the person and the part of the body affected.
Pregnant women: Pregnant women typically experience only fever and other flu-like symptoms, such as fatigue and muscle aches. However, infections during pregnancy can lead to miscarriage, stillbirth, premature delivery, or life-threatening infection of the newborn.
People other than pregnant women: Symptoms can include headache, stiff neck, confusion, loss of balance, and convulsions in addition to fever and muscle aches.
People with invasive listeriosis, a more serious form of the disease, usually report symptoms starting 1 to 4 weeks after eating food contaminated with Listeria; some people have reported symptoms starting as late as 70 days after exposure or as early as the same day of exposure. Listeriosis is treated with antibiotics.
Pregnant women and their newborns, adults age 65 and older, and people with weakened immune systems are more likely to get sick with listeriosis. Anyone with symptoms of listeriosis should contact a health care provider.
L. mono infections are uncommon in pets, but they are possible. Symptoms may include mild to severe diarrhea; anorexia; fever; nervous, muscular and respiratory signs; abortion; depression; shock; and death. Pets do not need to display symptoms to be able to pass L. mono on to their human companions. Once L. mono gets established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination may continue to spread. If your pet has these symptoms, consult a veterinarian promptly.
Why is the FDA concerned about Salmonella and L. mono in pet food?
Pet foods contaminated with pathogens such as Salmonella and L. mono are of particular public health importance because they can affect both human and animal health. Pets can get sick from Salmonella and L. mono, and may also be carriers of the bacteria and pass it onto their human companions without appearing to be ill. The FDA is aware of recent cases in which humans and/or animals have gotten sick from exposure to contaminated pet foods (Salmonella-human cases, Salmonella-kitten, Salmonella-kitten, dog).
Once Salmonella and/or L. mono get established in the pet’s gastrointestinal tract, the animal can shed the bacteria when it has a bowel movement, and the contamination will continue to spread. Because animals can shed the bacteria when they have bowel movements, it’s particularly important to clean up the animal’s feces in yards or parks where people or other animals may become exposed, in addition to cleaning items in the home.
Federal law, including the Federal Food, Drug, and Cosmetic Act, requires that all pet food not be contaminated with pathogens, including Salmonella and L. mono. Pet food manufacturers must effectively manage sourcing of ingredients, processing and packing to control pathogens. Without an effective control, such as cooking, raw pet food is more likely than other types of pet food to contain pathogens such as Salmonella and L. mono. Refrigeration or freezing does not kill the bacteria. Pet owners who choose to feed raw pet food should be aware of the risks associated with these products.
The FDA is the Federal agency that regulates pet food, while the United States Department of Agriculture (USDA) regulates meat and poultry for human consumption. USDA-regulated raw meat and poultry products are intended to be cooked and carry instructions to cook the product to a safe temperature. However, raw pet food products are intended to be served without further cooking, which creates a potential health hazard for people and pets exposed to the product.
How can I report a pet illness?
People who think their pets have become ill after consuming contaminated pet food should first contact their veterinarians. Veterinarians who wish to have pets tested for Salmonella may do so through the Vet-LIRN Network if the pet is from a household with a person infected with Salmonella. Veterinarians who wish to have pets tested for other pathogens when there is an associated human case may also contact Vet-LIRN.
The FDA encourages consumers to report complaints about this and other pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.
https://www.fda.gov/AnimalVeterinary/Ne ... 629711.htm
..........Traci