D-0224-2025 Class II Ongoing
FDA drug recall D-0224-2025 was initiated by AvKARE on January 21, 2025 and is designated Class II. Reason for recall: Out of Specification for Dissolution The recall status is ongoing. Affected quantity: 341 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- February 19, 2025
- Initiation Date
- January 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 341 cartons
Product Description
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Reason for Recall
Out of Specification for Dissolution
Distribution Pattern
Nationwide in the USA
Code Information
Lot 45279, Exp 03/31/2025