Recalls / Class II
Class IID-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
- 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
- Lots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023
Why it was recalled
Failed Dissolution Specifications; during stability testing
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
- 5,344 Bottles
- Distribution pattern
- Nationwide in the U.S.A
Timeline
- Recall initiated
- 2023-05-09
- FDA classified
- 2023-05-23
- Posted by FDA
- 2023-05-31
- Terminated
- 2024-02-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0761-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.