FDA Recall D-057-2013

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals · Huntsville, AL

Class I — life-threatening Ongoing 4994 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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

Lot / code: Lot number: C1440512A, Exp 12/13

Quantity: 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.

Recall record

Recall number: D-057-2013
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide.
Recall initiated: 2012-09-10
Classified by FDA Center: 2012-11-16
FDA published: 2012-11-28
Recalling firm: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Firm location: Huntsville, AL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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