HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21

Recall Number: D-057-2013

Firm: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Classification: Class I

Status: Ongoing

Report Date: 20121128

Initiation Date: 20120910

Termination Date:

Reason for Recall

Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.

Product Description

HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21