BREAKING NEWS: Leading Brand Issues Pet Medication Recall

BREAKING NEWS: Truxton, Inc. has announced a voluntary recall of lots of veterinary anticonvulsant, anti-seizure, and antidepressant medications containing phenobarbital and amitriptyline due to a label mix-up error.

According to the FDA, 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. Inadvertent exposure to or overdose of amitriptyline could cause uneven heartbeats, extreme drowsiness, confusion, agitation, vomiting, hallucinations, hot or cold sensations, muscle stiffness, seizures (convulsions), or fainting in humans and animals.

What to Look For:

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

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
0463-6145-10 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, and C.O. Truxton, Inc., is notifying all customers on record who have purchased any of the listed medications under the Truxton Incorporated label/NDC via US Mail with a recall letter and recall response form. The company is arranging for full credit returns or replacements of all recalled product.

What can you do?

If you have this product in your possession, discontinue use immediately, and return the medication for a full refund. If your pet shows signs of discomfort or illness, please contact your veterinarian as soon as possible.

You can contact C.O. Truxton at (800) 257-7704 from 9 a.m. to 5 p.m. EST Monday through Friday, or contact your nearest FDA consumer complaint coordinator with any questions. 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.

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