Drug product
BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-340-01; NDC Blister Pack: 60687-340-11
D-0328-2023
Product summary
- Event
- Event 91609
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,416 cartons
- Official record key
drug-enforcement:D-0328-2023
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: 1003837, Exp. Date 01/31/2023
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications