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.
Recall initiated: 20240624
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated