RecallDepth
Class I Ongoing

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

This recall is currently active, issued November 28, 2012. It was issued by Vintage Pharmaceuticals Llc, Dba Qualitest Pharmaceuticals.

Company
Vintage Pharmaceuticals Llc, Dba Qualitest Pharmaceuticals
Recall Initiated
September 10, 2012
Posted
November 28, 2012
Recall Number
D-057-2013
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
14,445 bottles
Firm Location
Huntsville, AL, United States
Official Source
View on FDA website ↗

Reason for Recall

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

Distribution

Nationwide.

Lot / Code Info

Lot number: C1440512A, Exp 12/13

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