D-0590-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 17, 2024
- Initiation Date
- June 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,484 cartons
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot 1017343, Exp. 12/31/2025