Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
Recall Number: D-0090-2022
Firm: Lupin Pharmaceuticals Inc.
Classification: Class II
Status: Terminated
Report Date: 20211110
Initiation Date: 20211012
Termination Date: 20230130
Reason for Recall
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Product Description
Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only