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.
FDA recall notice · announced July 17, 2024 · Amerisource Health Services
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Reason for recall
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Notes
Distribution: Nationwide in the USA
Lot/code information: Lot 1017343, Exp. 12/31/2025
Quantity: 2,484 cartons
Status: Ongoing
Products in this recall event:
- 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 (D-0590-2024)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.