Drug product
Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-504-01; NDC Unit Dose: 60687-504-11, barcode (01) 003 60687 504 11 7.
D-0536-2023
Product summary
- Event
- Event 91956
- Status
- Terminated
- Classification
- Class II
- Quantity
- 695 cartons
- Official record key
drug-enforcement:D-0536-2023
Official wording
Reason: Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Code information: Lots: 1008622, 1010026, Exp 2/29/24
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification