Errors with product labels have forced a nationwide recall of Amitriptyline HCL tablets and Phenobarbital tablets of varying dosages. Use could lead to adverse health issues, including intoxication, drowsiness, renal failure, seizures, uneven heartbeats, coma and more.
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 cause uneven heartbeats, extreme drowsiness, confusion, agitation, vomiting, hallucinations, hot or cold sensations, muscle stiffness, seizures (convulsions), or fainting in humans and animals.
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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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
