D-0857-2022 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 18, 2022
- Initiation Date
- April 29, 2022
- Termination Date
- September 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9804 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: a) JKX5126A, JKX5127A, JKX5128A, Exp 10/2022; b) JKX5126B , JKX5128B, Exp 10/2022; c)JKX5126C, JKX5127C, JKX5128C, Exp 10/2022;