Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKAR...
FDA Recall #D-0224-2025 — Class II — January 21, 2025
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
Recalling Firm
AvKARE — Pulaski, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
341 cartons
Distribution
Nationwide in the USA
Code Information
Lot 45279, Exp 03/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated