FDA-Drug2025-02-19Class II

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

AvKARE
Hazard

Out of Specification for Dissolution

Sold states
Nationwide in the USA
Affected count
341 cartons
Manufactured in
615 N 1st St, Pulaski, TN, United States
Products
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15

Official notice

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

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