FDA Recall D-0590-2024

Amerisource Health Services LLC · Columbus, OH

Class II Ongoing 689 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) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.

Lot / code: Lot 1017343, Exp. 12/31/2025

Quantity: 2,484 cartons

Reason for recall

Failed Dissolution Specifications; the product is dissolving faster than the specified limits.

Recall record

Recall number: D-0590-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-06-24
Classified by FDA Center: 2024-07-08
FDA published: 2024-07-17
Recalling firm: Amerisource Health Services LLC
Firm location: Columbus, OH

Drug identification

Brand name(s): BUPROPION HYDROCHLORIDE
Generic name(s): BUPROPION HYDROCHLORIDE
Manufacturer(s): American Health Packaging
NDC(s): 60687-782, 60687-793
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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