Safety

Company Announcement

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.

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

For Immediate Release

May 8, 2017

Contact

Consumers

Paul F. Devine
(800) 257-7704

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 NameNDC CodeLot NumberExpiration
Phenobarbital Tablets, USP 15mg (1000)0463-6160-1070915AAugust 2017
H15A55November 2017
70952ANovember 2017
71162AOctober 2018
Phenobarbital Tablets, USP 30mg (1000)0463-6145-1070926ANovember 2017
70981AJanuary 2018
H15A59August 2018
Phenobarbital Tablets, USP 60mg (1000)0463-6151-1070881AJuly 2017
H15A68January 2018
70980AFebruary 2018
71416AMay 2020
Phenobarbital Tablets, USP 100mg (100)0463-6152-0170989AFebruary 2018
70973AJanuary 2018
Phenobarbital Tablets, USP 100mg (1000)0163-6152-1070973AJanuary 2018
H15A76February 2018
71346ADecember 2019
Phenobarbital Tablets, USP 100mg (1000)0463-6152-0170989AFebruary 2018
Amitriptyline Tablets, USP 50mg (100)0463-6352-10C0260416AMarch 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:

NDCPackage SizeStrength (mg)Tablet Appearance Side OneTablet Appearance Side Two
0463-6160-10100015West-ward 445, whiteBlank, white
0463-6145-10100030West-ward 450, whiteScore line, white
0463-6151-10100060WW 455, whiteBlank, white
0463-6152-01100100WW 458, whiteScore line, white
0463-6152-101000100WW 458, whiteScore line, white

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

NDCPackage SizeStrength (mg)Tablet Appearance Side OneTablet Appearance Side Two
0463-6352-10100502103, beigeV, 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

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Page Last Updated: 05/09/2017
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