FDA-Drug2024-07-17Class II

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.

Amerisource Health Services LLC
Hazard

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

Sold states
Nationwide in the USA
Affected count
2,484 cartons
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0590-2024

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