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|
|Phenobarbital Tablets, USP 30mg (1000)||0463-6145-10||70926A||November 2017|
|Phenobarbital Tablets, USP 60mg (1000)||0463-6151-10||70881A||July 2017|
|Phenobarbital Tablets, USP 100mg (100)||0463-6152-01||70989A||February 2018|
|Phenobarbital Tablets, USP 100mg (1000)||0163-6152-10||70973A||January 2018|
|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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