Drug product
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
D-0761-2023
Product summary
- Event
- Event 92289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,344 Bottles
- Official record key
drug-enforcement:D-0761-2023
Official wording
Reason: Failed Dissolution Specifications; during stability testing
Code information: Lots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023
Distribution pattern: Nationwide in the U.S.A
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications