Drug product
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86
D-0446-2017
Product summary
- Event
- Event 76282
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,618 bottles
- Official record key
drug-enforcement:D-0446-2017
Official wording
Reason: Failed Dissolution Specifications; 18 month stability time point
Code information: JKP0905A 04/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications