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

FDA recall notice · announced February 27, 2013 · Mylan Institutional, Inc. (d.b.a. Udl Laboratories)

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: Lot #: 3037841, 3040859, 3042573, Exp 12/13
Quantity: 3,407 cartons
Status: Terminated
Products in this recall event:
- 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 (D-166-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.