Phenobarbital Recalled Due to Labeling Error

Published on: 

Truxton, Inc. is voluntarily recalling one lot of Phenobarbital Tablets, USP, 15 mg because of a labeling error on declared strength.

Truxton, Inc. (Bellmawr, NJ) announced on April 21, 2017 that it was voluntarily recalling lot 70952A of phenobarbital tablets, USP, 15 mg after the company received a customer complaint that a bottle labeled as phenobarbital 15 mg contained phenobarbital 30 mg tablets. The recalled product, which is used as a sedative or anticonvulsant, was distributed nationwide in the United States to physician and veterinarian treatment centers and is packaged in 1000 count bottles, NDC 0463-6160-10, UPC 7 0463616010 6, lot number 70952A, expiration date 11/17.

The company warns that overdosing of the product may cause severe intoxication, which could lead to cardiogenic shock, renal failure, coma, or death. The company stated in a press release that it had not had any reports of adverse events related to the recall. Adverse events can be reported to FDA through the agency’s website.


Source: FDA