D-0857-2022 Class III Terminated
FDA drug recall D-0857-2022 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Apr 29, 2022 and is designated Class III. 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… The recall status is terminated (terminated Sep 25, 2023). Affected quantity: 9804 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 18, 2022
- Initiation Date
- Apr 29, 2022
- Termination Date
- Sep 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;
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0857-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026