Recalls / Class II
Class IID-0222-2024
Product
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03
- Brand name
- Bupropion Hydrochloride
- Generic name
- Bupropion Hydrochloride
- Active ingredient
- Bupropion Hydrochloride
- Route
- Oral
- NDCs
- 16571-862, 16571-863
- FDA application
- ANDA211020
- Affected lot / code info
- Lot #: BPA123098A, Exp. Date 06/2025
Why it was recalled
Presence of Foreign Tablets/Capsules
Recalling firm
- Firm
- Rising Pharma Holding, Inc.
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1401, East Brunswick, New Jersey 08816-1149
Distribution
- Quantity
- 47,976 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-12-29
- FDA classified
- 2024-01-11
- Posted by FDA
- 2024-01-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0222-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.