FDA Recall D-166-2013

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · Rockford, IL

Class I — life-threatening Terminated 1334 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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 &amp; Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.

Lot / code: Lot #: 3037841, 3040859, 3042573, Exp 12/13

Quantity: 3,407 cartons

Reason for recall

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

Recall record

Recall number: D-166-2013
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2012-12-14
Classified by FDA Center: 2013-02-15
FDA published: 2013-02-27
Terminated: 2016-08-09
Recalling firm: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Firm location: Rockford, IL

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