Lupin

Date: 10/14/2021

Product Decsription

Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg

Recall Reason Description

API batches above the specification limit for the impurity, N-nitrosoirbesartan

Company Name

Lupin Pharmaceuticals, Inc.

US FDA Link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-all-irbesartan-tablets-and-irbesartan