Class I
Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.
- Recall Initiated
- December 14, 2012
- Posted
- February 27, 2013
- Recall Number
- D-166-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,407 cartons
- Firm Location
- Rockford, IL, United States
Reason for Recall
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Distribution
Nationwide
Lot / Code Info
Lot #: 3037841, 3040859, 3042573, Exp 12/13
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