Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 card...
FDA Recall #D-166-2013 — Class I — December 14, 2012
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.
Reason for Recall
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Recalling Firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) — Rockford, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
3,407 cartons
Distribution
Nationwide
Code Information
Lot #: 3037841, 3040859, 3042573, Exp 12/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated