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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

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
Recall Number D-057-2013
Classification Class I
Code Info Lot number: C1440512A, Exp 12/13
Product Distributed Qty 14,445 bottles
Reason For Recall Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.

Event Detail

Event Id 63138
Product Type Drugs
Status Ongoing
Recalling Firm Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
City Huntsville
State AL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-10
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Nationwide.