Drug product
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
D-0224-2025
Product summary
- Firm
- AvKARE
- Event
- Event 96172
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 341 cartons
- Official record key
drug-enforcement:D-0224-2025
Official wording
Reason: Out of Specification for Dissolution
Code information: Lot 45279, Exp 03/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of Specification