Multi event Drug Recall Enforcement Report Class III voluntary initiated by Sun Pharmaceutical Industries, Inc., originally initiated on 12-20-2016 for the 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 The product was recalled due to failed dissolution specifications; 18 month stability time point. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0446-2017 | 12-20-2016 | 02-01-2017 | Class III | 11,618 bottles | 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 | Failed Dissolution Specifications; 18 month stability time point | Terminated |
| D-0445-2017 | 12-20-2016 | 02-01-2017 | Class III | a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) 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 | Failed Dissolution Specifications; 18 month stability time point | Terminated |
Recalled Products
