drugs Class I Updated 2013-02-27

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg

Recalled Product

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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 3037841, 3040859, 3042573, Exp 12/13
View official government recall

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