Recall: D-0590-2024

Class II - Potentially Harmful

Class IIClassification

2024-06-24Initiated

OngoingStatus

Amerisource Health Services LLFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.