Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets Due to Potential Presence of N-nitrosoirbesartan Impurity

Date: 10/14/2021

Product type: Drugs, Impurity

Company Announcement Date: October 14, 2021
FDA Publish Date: October 14, 2021
Product Type: Drugs
Reason for Announcement: API batches above the specification limit for the impurity, N-nitrosoirbesartan
Company Name: Lupin Pharmaceuticals, Inc.
Brand Name: Lupin
Product Description: Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg

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