FDAHealthJanuary 21, 2025

AvKARE — Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15

⚠️ Out of Specification for Dissolution

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: January 21, 2025

Nationwide in the USA

What's affected?

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
Brand: IRBESARTAN
Lot code: 45279

Additional details

Lot 45279, Exp 03/31/2025

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 341 cartons.

View original FDA notice →

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