ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD

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Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD

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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
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Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD

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United Pet Group Voluntary Recalls Multiple Brands of Rawhide Chew Products for Dogs Due to Possible Chemical Contamination

June 10, 2017-
United Pet Group, a division of Spectrum Brands, Inc. is voluntarily recalling multiple brands of packages of rawhide dog chew products that were distributed to retail outlets and sold online in the U.S.

The recall was initiated after United Pet Group identified that certain of its rawhide chew manufacturing facilities located in Mexico and Colombia, as well as one of its suppliers in Brazil, were using a quaternary ammonium compound mixture as a processing aid in the manufacturing of rawhide chews. The compound is an anti-microbial chemical that is approved for cleaning food processing equipment, but it has not been approved in the U.S. as a processing aid in the production of rawhide chews for dogs.

United Pet Group received very limited reports of pet illness based on the volume of possibly affected rawhide chew products manufactured and distributed. The primary complaint received from consumers was that the affected product had an unpleasant odor. Diarrhea and vomiting were also reported.

Exposure to quaternary ammonium compounds through direct ingestion may cause the following symptoms in dogs: reduced appetite, and gastric irritation including diarrhea and vomiting. These symptoms may require treatment by a veterinarian depending on severity.


The affected product was distributed nationwide from United Pet Group’s Edwardsville, Illinois distribution facility and was delivered to consumers through various retail establishments including online outlets. All of the dog chew products included in the voluntary recall identify an expiration date ranging from 06/01/2019 through 05/31/2020 located on the back of the package.

The products subject to the recall are described below:

Product Brands / Product Names and Identifying Information

American Beefhide

United Pet Group is recalling certain packages of dog chews with the American Beefhide brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Manufactured by:
Salix Animal Health, LLC Deerfield Beach, FL 33442

Digest-eeze
United Pet Group is recalling certain packages of dog chews with the Digest-eeze brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB, and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Manufactured by:
Salix Animal Health, LLC Deerfield Beach, FL 33442

Healthy Hide (including Healthy Hide – Good -n- Fun and Healthy Hide – Good -n- Fit)
United Pet Group is recalling certain packages of dog chews with the Healthy Hide brand, Healthy Hide Good-n-Fit brand, and Healthy Hide Good-n-Fun brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

United Pet Group, a Division of Spectrum Brands, Inc. 3001 Commerce St. Blacksburg, VA 24060 1-800-645-5154

Consumers who have purchased the products described above are urged to dispose of the product or return it directly to United Pet Group or to the retail establishment where they initially purchased the product for full refund. Please see brand logos below which will assist in identifying affected products.

We take our responsibility to pets and their owners seriously and we are continuing to investigate the cause of this problem. We are implementing changes across the affected manufacturing facilities in order to prevent this problem from reoccurring in the future. United Pet Group is also working with retailers to ensure that the affected products are no longer sold and removed from inventory.

If you have these products, please contact the United Pet Group consumer affairs team at 1-855-215-4962 between the hours of 8:00 AM – 11:00 PM Eastern Standard Time for a refund.

Consumers with questions may call the consumer affairs team at the number listed above.

This voluntary recall is being conducted with the knowledge of the Food and Drug Administration.

More info and product label photos included here:
https://www.fda.gov/Safety/Recalls/ucm562701.htm
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Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD

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Loving Pets Voluntarily Recalls Limited Lot Numbers of Air-Puffed Dog Treats Because of Possible Salmonella Health Risk

June 14, 2017-
Loving Pets of Cranbury, NJ is voluntarily recalling a limited number of dog treats because of 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.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: 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.

The lot numbers included are:

Loving Pets Barksters

- Item #5700 Sweet Potato and Chicken UPC 842982057005 - Lot # 021619
- Item #5705 Brown Rice and Chicken UPC 842982057050 - Lot 021419

Loving Pets Puffsters™ Snack Chips

- Item #5100 Apple and Chicken UPC 842982051003 - Lot 051219, 112118, 112918, 012719, 012519, 013019
- Item #5110 Banana and Chicken UPC 842982051102 - Lot 112218, 112818, 112918, 013119
- Item #5120 Sweet Potato and Chicken UPC 842982051201 - Lot 112818, 020119
- Item #5130 Cranberry and Chicken UPC 842982051300 - Lot 020319, 112918, 020219

Whole Hearted

- Item #2570314 Chicken and Apple Puff Treats UPC 800443220696 - Lot 121418, 121918, 122318, 010419, 010619, 010519


No illnesses, injuries or complaints have been reported.

The possible Salmonella contamination was due to a single finished ingredient that was supplied to Loving Pets from a USA based supplier. This possible contamination was discovered by Loving Pets' internal quality assurance team and was identified through the company's standard quality control testing procedures and internal food safety program. Loving Pets produces its treats in small batches, in order to offer the highest quality and control in safety.

To ensure the safety of its products, Loving Pets decided to be extra cautious and recall a wider range of lot numbers (noted above) so that no possible contaminated product is available on the market.

Consumers may return any bag of treats with any of these aforementioned lot numbers to the retailer where the product was originally purchased. For additional information, please visit www.LovingPetsProducts.com or call 866-599-PETS (7387).


https://www.fda.gov/Safety/Recalls/ucm563210.htm
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Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD

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United Pet Group Expands Voluntary Recall of Multiple Brands of Rawhide Chew Products for Dogs to Also Include Private Label Brands Due to Possible Chemical Contamination

June 16, 2017
United Pet Group, a division of Spectrum Brands, Inc. is voluntarily expanding its recall of multiple brands of packages of rawhide dog chew products to include our retail partners’ private label brands. The recall involves the brands and products described below.

United Pet Group previously initiated a voluntary recall of its branded products on 6/10/17 which included the following brands: American Beefhide, Digest-eeze, and Healthy Hide (including Healthy Hide – Good -n- Fun and Healthy Hide – Good -n- Fit).

The recall was initiated after United Pet Group identified that certain of its rawhide chew manufacturing facilities located in Mexico and Colombia, as well as one of its suppliers in Brazil, were using a quaternary ammonium compound mixture as a processing aid in the manufacturing of rawhide chews. The compound is an anti-microbial chemical that is approved for cleaning food processing equipment, but it has not been approved in the U.S. as a processing aid in the production of rawhide chews for dogs.

United Pet Group received very limited reports of pet illness based on the volume of possibly affected rawhide chew products manufactured and distributed. The primary complaint received from consumers was that the affected product had an unpleasant odor. Diarrhea and vomiting were also reported.

Exposure to quaternary ammonium compounds through direct ingestion may cause the following symptoms in dogs: reduced appetite and gastric irritation, including diarrhea and vomiting. These symptoms may require treatment by a veterinarian depending on severity
.

The affected product was distributed nationwide from United Pet Group’s Edwardsville, Illinois distribution facility and was delivered to consumers through various retail establishments, including online outlets. All of the dog chew products included in the voluntary recall identify an expiration date ranging from 06/01/2019 through 5/31/2020 located on the back of the package with the exception of the Enzadent and Dentahex products which are listed by UPC codes below and specific expiration dates outlined below.

The private label products subject to the recall are described below:

Private Label Product Brands / Private Label Product Names and Identifying Information

Companion
:

United Pet Group is recalling certain packages of dog chews with the Companion brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Distributed by FOODHOLD U.S.A., LLC LANDOVER, MD 20785 1-877-846-9946

Dentley's:

United Pet Group is recalling certain packages of dog chews with the Dentley’s brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Pacific Coast Distributing, Inc. 19601 N. 27th Ave. Phoenix, AZ USA 85027

Enzadent or Dentahex:

United Pet Group is recalling certain packages of dog chews with the Enzadent/Dentahex brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with the below listed UPC codes printed on the back of the package and which list expiration dates from 06/01/2021 through 05/31/2022 are affected by this recall. The following contact information appears on the back of the package of the affected products:

ENZADENT CHIPS MED 30 CT 17030030181
ENZADENT CHIPS PETITE 30 CT 17030030167
ENZADENT CHIPS SM 30 CT 17030030174
ENZADENT CHIPS LG 30 CT 17030030198
DENTAHEX CHIPS PETITE 30 CT 17030030228
DENTAHEX CHIPS SM 30 CT 17030030235
DENTAHEX CHIPS MED 30 CT 17030030242
DENTAHEX CHIPS LG 30 CT 17030030259

Manufactured for Vetoquinol USA Inc. Ft. Worth, TX USA 76137

Essential Everyday:

United Pet Group is recalling certain packages of dog chews with the Essential Everyday brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Distributed by SUPERVALU INC. EDEN PRAIRIE, MN 55344 USA

Exer-Hides:

United Pet Group is recalling certain packages of dog chews with the Exer-Hides brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716

Good Lovin' or Petco:

United Pet Group is recalling certain packages of dog chews with the Good Lovin’ or Petco brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Distributed by: International Pet Supplies and Distribution, Inc. San Diego, CA 92121

Hill Country Fare:

United Pet Group is recalling certain packages of dog chews with the Hill Country Fare brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Distributed by H-E-B San Antonio, TX 78204

Priority Pet:

United Pet Group is recalling certain packages of dog chews with the Priority brand on the label.

This recall is limited to dog chew products that contain rawhide. Only products with lot codes listed on the back of the package that start with AH, AV, A, AI, AO, or AB and which list expiration dates from 06/01/2019 through 05/31/2020 are affected by this recall. This includes all package sizes and/or weights. The following contact information appears on the back of the package of the affected products:

Distributed by Lucerne North America LLC
P.O. Box 99
Pleasanton, CA 94566-0009
1-866-578-4395

Consumers who have purchased the products described above are urged to dispose of the product or return it directly to United Pet Group or to the retail establishment where they initially purchased the product for full refund. Please see brand logos below which will assist in identifying affected

We take our responsibility to pets and their owners seriously and we are continuing to investigate the cause of this problem. We are implementing changes across the affected manufacturing facilities in order to prevent this problem from reoccurring in the future. United Pet Group is also working with retailers to ensure that the affected products are no longer sold and removed from inventory.

If you have these products, please contact the United Pet Group consumer affairs team at 1-855-215-4962 between the hours of 8:00 AM – 11:00 PM Eastern Standard Time for a refund.

Consumers with questions may call the consumer affairs team at the number listed above.

The expansion of this voluntary recall is being conducted with the knowledge of the Food and Drug Administration.


More Info and Product Label Photos here:
https://www.fda.gov/Safety/Recalls/ucm563544.htm
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Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD

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FDA ISSUES WARNING LETTER TO EVANGER'S FOR VIOLATIONS REGARDING PENTOBARBITOL IN PET FOOD

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

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ADMIN NOTE: PLEASE READ THE FOLLOWING TWO POSTS CAREFULLY, SALMONELLA AND LISTERIA CAN BE DEADLY TO 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
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Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD

Post by 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
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Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD

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FDA Alerts Pet Owners About Potential Pentobarbital Contamination in Canned Dog Foods Manufactured by The J.M. Smucker Company, Including Certain Gravy Train, Kibbles ‘N Bits, Ol’ Roy, and Skippy Products

February 16, 2018 -
The U.S. Food and Drug Administration is investigating potential contamination with the barbiturate pentobarbital in certain canned dog food products manufactured by The J.M. Smucker Company.

* The FDA is alerting pet owners about potential pentobarbital contamination in certain canned dog foods manufactured by The J.M. Smucker Company.

* After learning about positive pentobarbital results in certain cans of Gravy Train dog food, J.M. Smucker initiated a withdrawal of various canned dog food products from its Gravy Train, Kibbles ‘N Bits, Ol’ Roy, and Skippy brands.

* The FDA’s preliminary evaluation of the testing results of Gravy Train samples indicates that the low level of pentobarbital present in the withdrawn products is unlikely to pose a health risk to pets. However, pentobarbital should never be present in pet food and products containing any amount of pentobarbital are considered to be adulterated.

* The FDA is monitoring for reports of any pet illnesses associated with pentobarbital contamination in these products. Consumers can report complaints about this and other pet food products electronically through the Safety Reporting Portal or by calling their local FDA Consumer Complaint Coordinators.

What is the Problem and What is Being Done About It?

The J.M. Smucker Company has initiated a withdrawal of certain canned dog food products from its Gravy Train, Kibbles ‘N Bits, Ol’ Roy, and Skippy brands due to the potential for pentobarbital contamination. The firm is withdrawing all lots of these products that were manufactured from 2016 through the present. The FDA is issuing this notice in order to make pet owners aware of the firm’s action.

The withdrawn products were distributed to retailers nationwide.

The list of withdrawn products the firm provided to the FDA include:

* Gravy Train with T-Bone Flavor Chunks, 13.2-ounce can, UPC 7910052541

* Gravy Train with Beef Strips, 13.2-ounce can, UPC 791052542

* Gravy Train with Lamb & Rice Chunks, 13.2-ounce can, UPC 7910052543

* Gravy Train with Chicken Chunks, 13.2-ounce can, UPC 7910034418

* Gravy Train with Beef Chunks, 13.2-ounce can, UPC 7910034417

* Gravy Train with Chicken Chunks, 22-ounce can, UPC 7910051645

* Gravy Train with Beef Chunks, 22-ounce can, UPC 7910051647

* Gravy Train Chunks in Gravy with Beef Chunks, 13.2-ounce can, UPC 7910034417

* Kibbles ‘N Bits 12-can Variety Pack – Chef’s Choice American Grill Burger Dinner with Real Bacon & Cheese Bits in Gravy, Chef’s Choice Bistro Tender Cuts with Real Turkey Bacon & Vegetables in Gravy, 12 pack of 13.2-ounce cans, UPC 7910010377, 7910010378

* Kibbles ‘N Bits 12-Can Variety Pack – Chef’s Choice Bistro Hearty Cuts with Real Beef, Chicken & Vegetables in Gravy, Chef’s Choice Homestyle Meatballs & Pasta Dinner with Real Beef in Tomato Sauce, 12 pack of 13.2-ounce cans, UPC 7910010382, 7910048367, 7910010378

* Kibbles ‘N Bits 12-Can Variety Pack – Chef’s Choice Homestyle Tender Slices with Real Beef, Chicken & Vegetables in Gravy, Chef’s Choice American Grill Burger Dinner with Real Bacon & Cheese Bits in Gravy, Chef’s Choice Bistro Tender Cuts with Real Beef & Vegetables in Gravy, 12 pack of 13.2-ounce cans, UPC 7910010380, 7910010377, 7910010375

* Kibbles ‘N Bits Chef’s Choice Bistro Tender Cuts with Real Beef & Vegetables in Gravy, 13.2-ounce can, UPC 7910010375

* Kibbles ‘N Bits Chef’s Choice Bistro Tender Cuts with Real Turkey, Bacon & Vegetables in Gravy, 13.2-ounce can, UPC 7910010378

* Kibbles ‘N Bits Chef’s Choice Homestyle Tender Slices with Real Beef, Chicken & Vegetables in Gravy, 13.2-ounce can, UPC 7910010380

* Ol’ Roy Strips Turkey Bacon, 13.2-ounce can, UPC 8113117570

* Skippy Premium Chunks in Gravy Chunky Stew, 13.2-ounce can, UPC 79100502469

* Skippy Premium Chunks in Gravy with Beef, 13.2-ounce can, UPC 7910050250

* Skippy Premium Strips in Gravy with Beef, 13.2-ounce can, UPC 7910050245


The FDA has become aware of reports of other products also subject to withdrawal. The FDA has requested clarification from Smuckers regarding the status of these other products.

Pentobarbital is a barbiturate drug that is most commonly used in animals as a sedative, anesthetic, or for euthanasia. The FDA’s preliminary evaluation of the testing results of Gravy Train samples indicates that the low level of pentobarbital present in the withdrawn products is unlikely to pose a health risk to pets. However, any detection of pentobarbital in pet food is a violation of the Federal Food, Drug, and Cosmetic Act—simply put, pentobarbital should not be in pet food . The FDA is investigating to learn the potential source and route of the contamination.

What Happens to a Pet That Eats Pet Food Containing Pentobarbital?

Pets that eat pet food containing pentobarbital can experience drowsiness, dizziness, excitement, loss of balance, nausea, nystagmus (eyes moving back and forth in a jerky manner) and inability to stand. Consuming high levels of pentobarbital can cause coma and death. However, pentobarbital present in the withdrawn products is at a low level unlikely to pose a health risk to pets.

What Do Retailers Need To Do?

Retailers should remove the withdrawn pet food from their shelves and/or website and contact the manufacturer for further instructions. If retailers have records to identify consumers who have purchased the withdrawn product, the FDA encourages those retailers to contact the consumers to alert about the product withdrawal.

What Do Consumers Need To Do?

Consumers should not feed their pets the withdrawn lots of J.M. Smucker pet food. Consumers who purchased these products should safely dispose of the cans and/or contact the firm for information about returning the product.

Pet owners who think their pets may be ill from eating food contaminated with pentobarbital should contact their veterinarians.

Who Should be Contacted?

People who think their pets have become ill after consuming pet food contaminated with pentobarbital should contact their veterinarians.

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.


FDA page for this announcement:
https://www.fda.gov/AnimalVeterinary/Ne ... 597135.htm
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Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD

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TruPet, LLC Issues Voluntary Recall of Certain "Treat Me Crunchy Beef Delight" Pet Treats



February 23, 2018 -
TruPet, LLC of Milford, OH, is voluntarily recalling a limited amount of Treat Me Crunchy Beef Delight, 2.5oz Pet treats because the products have the potential to be contaminated with Salmonella. The recall includes only the product listed below.

The following affected "Treat Me Crunchy Beef Delight" products were distributed in the continental USA via online retailer Chewy.com and TruDog.com through direct delivery:

Affected product can be identified by comparing the following lot number: "Treat Me Crunchy Beef Delight" with "Lot # 20190514 13753".

No products other than the specific product identified above are subject to this voluntary recall.

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.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: 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.

The recall is being issued in an abundance of caution following the Michigan Department of Agriculture’s collection of a retail sample from a single batch which tested positive. No illnesses have been reported to date.

Consumers who have purchased Treat Me Crunchy Beef Delight are urged to return effected product to the place of purchase for a refund. Consumers with questions may call the company at 800-476-8808 for additional information.


More information and product label photo here:
https://www.fda.gov/Safety/Recalls/ucm598161.htm
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Re: ALL POSTS RE: PET FOOD RECALLS GO HERE IN THIS THREAD

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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
..........Traci
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