Drug product
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-737-86
D-0044-2024
Product summary
- Event
- Event 93166
- Status
- Terminated
- Classification
- Class III
- Quantity
- 144 bottles
- Official record key
drug-enforcement:D-0044-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: HAD0360A, Exp. 12/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications