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Nationwide Recall of Hydrocodone Bitartrate and Acetaminophen Tablets

The FDA has announced a nationwide (retail level) recall for one lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, as it has been determined that some tablets from the lot exceed the weight specification, and could be “super-potent” for the ingredients Hydrocodone Bitartrate and Acetaminophen.
The recall affects the following:

  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, expiration date 12/13

The affected lot was distributed between May 14 and Aug. 3, 2012 to wholesale distributors and retail pharmacies nationwide. The lot number is located on the side of the manufacturer’s bottle. Hydrocodone Bitartrate and Acetaminophen Tablets are approximately 16.51 mm in length, pink, capsule-shaped tablets, with “3600” debossed on one side of the tablet and “V” on the other.
No injuries have been reported to date.

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