Drug product
buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86
D-1446-2016
Product summary
- Event
- Event 74696
- Status
- Terminated
- Classification
- Class III
- Quantity
- 16,085 bottles
- Official record key
drug-enforcement:D-1446-2016
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot JKN3477A, exp 07/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications