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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Product Detail

Product Description 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 Number D-166-2013
Classification Class I
Code Info Lot #: 3037841, 3040859, 3042573, Exp 12/13
Product Distributed Qty 3,407 cartons
Reason For Recall Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.

Event Detail

Event Id 63899
Product Type Drugs
Status Ongoing
Recalling Firm Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
City Rockford
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide