Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 bl
Recalled February 27, 2013 · FDA recall D-166-2013 · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Hazard
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. · FDA Class I
Units
3,407 cartons
Sold at
Nationwide
Description
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
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.
Manufacturer(s)
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →