FDA recall D-0590-2024

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.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-06-24

Report date

2024-07-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

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