UPDATE MAY 8 2017 - PHENOBARBITAL *AND* AMITRIPTYLINE RECALL

[Traci]

C.O. Truxton, Inc. Issues Voluntary Nationwide Recall of Amitriptyline HCL Tablets, USP 50mg and Phenobarbital Tablets, USP 15mg, 30mg, 60mg, 100mg Due to Potential Label Mix-Up

May 8 2017 -

Bellmawr, New Jersey, C.O. Truxton, Inc. is expanding their - 04/21/2017 voluntary recall, as a precaution to include the following C.O. Truxton, Inc. products, registered NDC numbers and corresponding lot numbers, to the consumer/user level. C.O. Truxton has not received any complaints for the products listed below - however, due to the initial recall resulting from a label mix-up error, out of an abundance of caution, we are recalling all products that were repackaged into a Truxton Incorporated label.

Product Name / NDC Code / Lot Number / Expiration

Phenobarbital Tablets, USP 15mg (1000) / 0463-6160-10 / 70915A / August 2017
H15A55 / November 2017
70952A / November 2017
71162A / October 2018
Phenobarbital Tablets, USP 30mg (1000) 0463-6145-10 / 70926A / November 2017
70981A / January 2018
H15A59 / August 2018
Phenobarbital Tablets, USP 60mg (1000) 0463-6151-10 / 70881A / July 2017
H15A68 / January 2018
70980A / February 2018
71416A / May 2020
Phenobarbital Tablets, USP 100mg (100) 0463-6152-01 / 70989A / February 2018
70973A / January 2018
Phenobarbital Tablets, USP 100mg (1000) 0163-6152-10 / 70973A / January 2018
H15A76 / February 2018
71346A / December 2019
Phenobarbital Tablets, USP 100mg (1000) 0463-6152-01 / 70989A / February 2018

Amitriptyline Tablets, USP 50mg (100) 0463-6352-10 / C0260416A / March 2018

If mislabeled, inadvertent exposure to, or overdose of phenobarbital could cause severe intoxication which may lead to cardiogenic shock, renal failure, coma, or death in humans and animals.

If mislabeled, inadvertent exposure to, or overdose of amitriptyline could causeuneven heartbeats, extreme drowsiness, confusion, agitation, vomiting, hallucinations, hot or cold sensations, muscle stiffness, seizures (convulsions), or fainting in humans and animals. C.O. Truxton, Inc. has not received any reports of adverse events related to this recall.

Phenobarbital is indicated for use as a sedative or anticonvulsant and is packaged in the following configurations:

NDC / Package Size / Strength (mg) / Tablet Appearance Side One / Tablet Appearance Side Two

0463-6160-10 / 1000 / 15 /West-ward 445, white / Blank, white
0463-6145-10 / 1000 / 30 /West-ward 450, white / Score line, white
0463-6151-10 / 1000 / 60 /WW 455, white / Blank, white
0463-6152-01 / 100 / 100 /WW 458, white / Score line, white
0463-6152-10 / 1000 / 100 /WW 458, white / Score line, white

Amitriptyline is indicated for use as a tricyclic antidepressant and is packaged in the following configuration:

NDC / Package Size / Strength (mg) / Tablet Appearance Side One / Tablet Appearance Side Two

0463-6352-10 / 100 / 50 / 2103, beige / V, beige

The product was distributed nationwide in the U.S.A. to physician & veterinarian treatment centers.

C.O. Truxton, Inc. is notifying all customers on record who purchased the above listed products under Truxton Incorporated label/NDC via US Mail with a recall letter and recall response form. C.O. Truxton, Inc. and is arranging for full credit returns, replacements, etc. of all recalled product. Consumers/distributors/retailers that have recalled product should stop using the product immediately and return their product to the place of purchase.

Consumers with questions regarding this recall can contact C.O Truxton, Inc. by phone at (800) 257-7704, Monday to Friday between the hours of 9am and 5pm (EST). Consumers should contact their physician, healthcare provider, or veterinarian if they have experienced any problems that may be related to taking or administering these drug products.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax.

- Complete and submit the report Online: www.fda.gov/medwatch/report.htm

- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit a fax to 1-800-FDA-0178

- For reporting animal adverse drug events and product defects, please follow the link to the directions and the FORM FDA 1932a found at: http://www.fda.gov/AnimalVeterinary/Saf ... 055305.htm

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

Link to original Phenobarbital Recall in April 2017


https://www.fda.gov/Safety/Recalls/ucm557260.htm