FDA Recall D-0222-2024

Rising Pharma Holding, Inc. · East Brunswick, NJ

Class II Ongoing 867 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot #: BPA123098A, Exp. Date 06/2025

Quantity: 47,976 bottles

Reason for recall

Presence of Foreign Tablets/Capsules

Recall record

Recall number: D-0222-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2023-12-29
Classified by FDA Center: 2024-01-11
FDA published: 2024-01-17
Recalling firm: Rising Pharma Holding, Inc.
Firm location: East Brunswick, NJ

Drug identification

Brand name(s): BUPROPION HYDROCHLORIDE
Generic name(s): BUPROPION HYDROCHLORIDE
Manufacturer(s): Rising Pharma Holdings, Inc.
NDC(s): 16571-862, 16571-863
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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