Recalls / Class III
Class IIID-0044-2024
Product
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, 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, 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
- Lot #: HAD0360A, Exp. 12/2023
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, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 144 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-10-04
- FDA classified
- 2023-10-16
- Posted by FDA
- 2023-10-25
- Terminated
- 2024-02-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0044-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.