Why it was recalled
Presence of Foreign Tablets/Capsules
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: BPA123098A, Exp. Date 06/2025
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0222-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 29, 2023
- FDA report date
- Jan 17, 2024
- Quantity
- 47,976 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rising Pharma Holding, Inc.
Original FDA data
Every field from FDA enforcement report D-0222-2024, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 93706
- Address
- 2 Tower Center Blvd Ste 1401
- Code information
- Lot #: BPA123098A, Exp. Date 06/2025
- Postal code
- 08816-1149
- Report date
- Jan 17, 2024
- Product type
- Drugs
- Recall number
- D-0222-2024
- Classification
- Class II
- Recalling firm
- Rising Pharma Holding, Inc.
- Product quantity
- 47,976 bottles
- Reason for recall
- Presence of Foreign Tablets/Capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 29, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 11, 2024