Drug recall D-0761-2023
Product
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
Reason for recall
Failed Dissolution Specifications; during stability testing
Lots and codes
Lots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 5,344 Bottles
- Distribution
- Nationwide in the U.S.A
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 9, 2023
- Terminated
- February 27, 2024
Related products
- Bupropion hydrochloride – drug information
- NDC 47335-737 Bupropion hydrochloride · Bupropion Hydrochloride 150 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-736 Bupropion hydrochloride · Bupropion Hydrochloride 100 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-738 Bupropion hydrochloride · Bupropion Hydrochloride 200 mg/1 · Sun Pharmaceutical Industries, Inc.