Drug product
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86
D-0007-2017
Product summary
- Event
- Event 75206
- Status
- Terminated
- Classification
- Class III
- Quantity
- 31,762 bottles
- Official record key
drug-enforcement:D-0007-2017
Official wording
Reason: Failed Dissolution Specifications
Code information: JKN5124A and JKN5229A, exp 10/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications