Drug product
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86
D-1345-2015
Product summary
- Event
- Event 71949
- Status
- Terminated
- Classification
- Class III
- Quantity
- 35,235 bottles
- Official record key
drug-enforcement:D-1345-2015
Official wording
Reason: Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Code information: Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification