D-166-2013 Class I Terminated
FDA drug recall D-166-2013 was initiated by Mylan Institutional, Inc. (D.B.A. UDL Laboratories) on Dec 14, 2012 and is designated Class I. Reason for recall: Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. The recall status is terminated (terminated Aug 9, 2016). Affected quantity: 3,407 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 27, 2013
- Initiation Date
- Dec 14, 2012
- Termination Date
- Aug 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,407 cartons
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.
Distribution Pattern
Nationwide
Code Information
Lot #: 3037841, 3040859, 3042573, Exp 12/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-166-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026