Drug product
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
D-0436-2023
Product summary
- Event
- Event 91670
- Status
- Terminated
- Classification
- Class II
- Quantity
- 422 cartons
- Official record key
drug-enforcement:D-0436-2023
Official wording
Reason: Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Code information: Lot 1009065, Exp 12/31/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification