Drug product
NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.
D-0413-2018
Product summary
- Firm
- ALLERGAN
- Event
- Event 79080
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8 bottles
- Official record key
drug-enforcement:D-0413-2018
Official wording
Reason: Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Code information: Lot # 544821A, Exp 07/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.