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