Drug product
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102
D-0836-2018
Product summary
- Firm
- LUPIN SOMERSET
- Event
- Event 80187
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,672 (1000-count) bottles
- Official record key
drug-enforcement:D-0836-2018
Official wording
Reason: Labeling: Missing Label
Code information: Lot # S800257; Exp. 01/20
Distribution pattern: OH
Derived failure modes
-
Labeling or packaging
Labeling: Missing