PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: February 19, 2025 Initiated: January 21, 2025 #D-0224-2025

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

Details

Recalling Firm
AvKARE
Units Affected
341 cartons
Distribution
Nationwide in the USA
Location
Pulaski, TN

Frequently Asked Questions

What product was recalled?
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15. Recalled by AvKARE. Units affected: 341 cartons.
Why was this product recalled?
Out of Specification for Dissolution
Which agency issued this recall?
This recall was issued by the FDA Drug on February 19, 2025. Severity: Moderate. Recall number: D-0224-2025.