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FDA Announces Voluntary Recall of Hydrocodone Bitartrate/Acetaminophen and Phenobarbital Products


 

The Food and Drug Administration announced Feb. 5 a voluntary, nationwide recall of certain lots of hydrocodone bitartrate and acetaminophen tablets and also certain lots of phenobarbital tablets. The tablets were manufactured by Qualitest Pharmaceuticals, a subsidiary of Endo Pharmaceuticals.

A single bottle of hydrocodone bitartrate and acetaminophen tablets was incorrectly labeled as phenobarbital. As a result, the company is recalling the following products:

Hydrocodone bitartrate and acetaminophen tablets (USP 10 mg/500 mg, NDC 0603-3888-20, 60 count). The affected lot numbers are T150G10B, T120J10E, and T023M10A.

Phenobarbital tablets (USP 32.4 mg, NDC 0603-5166-32, 1,000 count). The affected lot numbers are T150G10B, T120J10E, and T023M10A.

The company distributed the lots widely throughout the United States, including Puerto Rico, between Sept. 21 and Dec. 29, 2010.

No injuries have been reported.