U.S. flag An official website of the United States government
  1. Home
  2. Safety
  3. Recalls, Market Withdrawals, & Safety Alerts
  4. 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
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

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

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Read Announcement

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Animal & Veterinary
Drugs
Reason for Announcement:
Recall Reason Description
Label Mix-up Error
Company Name:
C.O. Truxton, Inc.
Brand Name:
Brand Name(s)
Truxton Incorporated
Product Description:
Product Description
Amitriptyline HCL Tablets, USP 50mg andPhenobarbital Tablets, USP 15mg, 30mg, 60mg, 100mg

Company Announcement

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.

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

Link to original PR

Consumers

Paul F. Devine
(800) 257-7704