Drug product
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.
D-0037-2026
Product summary
- Event
- Event 97629
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 46,512/30 count bottles
- Official record key
drug-enforcement:D-0037-2026
Official wording
Reason: Failed Tablet/Capsule Specifications
Code information: Batch # BPB124341A, Exp date: 10/2026
Distribution pattern: Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications