Drug product
Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.
D-058-2013
Product summary
- Event
- Event 63246
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4,874 bottles
- Official record key
drug-enforcement:D-058-2013
Official wording
Reason: Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Code information: Lot #: 519406A, 521759A, Exp 04/14
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent