Drug recall D-0857-2022
Product
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India
Reason for recall
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Lots and codes
Lot #: a) JKX5126A, JKX5127A, JKX5128A, Exp 10/2022; b) JKX5126B , JKX5128B, Exp 10/2022; c)JKX5126C, JKX5127C, JKX5128C, Exp 10/2022;
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 9804 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 29, 2022
- Terminated
- September 25, 2023
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.