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 & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.
D-166-2013
Product summary
- Event
- Event 63899
- Status
- Terminated
- Classification
- Class I
- Quantity
- 3,407 cartons
- Official record key
drug-enforcement:D-166-2013
Official wording
Reason: Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Code information: Lot #: 3037841, 3040859, 3042573, Exp 12/13
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent