buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 1...
FDA Recall #D-0590-2024 — Class II — June 24, 2024
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.
Reason for Recall
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Recalling Firm
Amerisource Health Services LLC — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,484 cartons
Distribution
Nationwide in the USA
Code Information
Lot 1017343, Exp. 12/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated