Drug product
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86
D-0137-2024
Product summary
- Event
- Event 93472
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2016 Bottles
- Official record key
drug-enforcement:D-0137-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot HAD0630A, exp 1/2024
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications