Drug product
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
D-0878-2023
Product summary
- Event
- Event 92524
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3876 cartons
- Official record key
drug-enforcement:D-0878-2023
Official wording
Reason: Packaging defect: blister packaging inadequately sealed.
Code information: Lot #: M04343, Exp. 04/2024
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Labeling or packaging
Packaging defect