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
- 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
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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