C. O. Truxton Issues Voluntary Nationwide Recall Of Amitriptyline HCL Tablets, USP 50mg And Phenobarbital Tablets, USP 15mg, 30mg, 60mg, 100mg Due To Potential Label Mix-Up

BELLMAWR, N.J., May 5, 2017 /PRNewswire/ -- 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 cause uneven 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.

Company Contact:

C.O. Truxton, Inc.
Mr. Paul F. Devine
(800) 257-7704

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/co-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-300452554.html

SOURCE C.O. Truxton, Inc.

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