Drug 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.
D-0590-2024
Product summary
- Event
- Event 94891
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,484 cartons
- Official record key
drug-enforcement:D-0590-2024
Official wording
Reason: Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Code information: Lot 1017343, Exp. 12/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications