Recalls / Class III
Class IIID-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
- Brand name
- Bupropion Hydrochloride
- Generic name
- Bupropion Hydrochloride
- Active ingredient
- Bupropion Hydrochloride
- Route
- Oral
- NDCs
- 47335-736, 47335-737, 47335-738
- FDA application
- ANDA078866
- Affected lot / code info
- Lot #: a) JKX5126A, JKX5127A, JKX5128A, Exp 10/2022; b) JKX5126B , JKX5128B, Exp 10/2022; c)JKX5126C, JKX5127C, JKX5128C, Exp 10/2022;
Why it was recalled
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.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 9804 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-04-29
- FDA classified
- 2022-05-10
- Posted by FDA
- 2022-05-18
- Terminated
- 2023-09-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0857-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.