Drug product
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03
D-0222-2024
Product summary
- Event
- Event 93706
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 47,976 bottles
- Official record key
drug-enforcement:D-0222-2024
Official wording
Reason: Presence of Foreign Tablets/Capsules
Code information: Lot #: BPA123098A, Exp. Date 06/2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets