FDA recall D-166-2013

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · Class I · drug

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.

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-12-14
Report date: 2013-02-27
Termination date: 2016-08-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-166-2013