FDA recall D-0224-2025

AvKARE · Class II · 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

Reason for recall

Out of Specification for Dissolution

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-01-21
Report date: 2025-02-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0224-2025