← FDA ENFORCEMENT
D-0590-2024Class II

Amerisource Health Services LLC

Recalling firm
Amerisource Health Services LLC
Product type
Drug
Status
Ongoing
Report date
2024-07-17
Distribution
Nationwide in the USA
Firm state
OH
Product quantity
2,484 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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.

Code / lot info

Lot 1017343, Exp. 12/31/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.