buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Recall Number: D-0761-2023
Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Classification: Class II
Status: Terminated
Report Date: 20230531
Initiation Date: 20230509
Termination Date: 20240227
Reason for Recall
Failed Dissolution Specifications; during stability testing
Product Description
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86