Recalls / Class III
Class IIID-0137-2024
Product
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86
- 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
- Lot HAD0630A, exp 1/2024
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 2016 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-11-22
- FDA classified
- 2023-12-01
- Posted by FDA
- 2023-12-13
- Terminated
- 2024-06-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0137-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.