Product: 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
Reason for recall: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Recall initiated: 20211012
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated