FDAFDA · Food and drugs·Recall number D-166-2013
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.
Published February 27, 2013 · Recall initiated: December 14, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Distributor
- Nationwide
- Lot
- Lot #: 3037841, 3040859, 3042573, Exp 12/13
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States