PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: July 17, 2024 Initiated: June 24, 2024 #D-0590-2024

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.

Details

Units Affected
2,484 cartons
Distribution
Nationwide in the USA
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
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.. Recalled by Amerisource Health Services LLC. Units affected: 2,484 cartons.
Why was this product recalled?
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 17, 2024. Severity: Moderate. Recall number: D-0590-2024.