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: CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Code information: a) Lot# H804192, exp. date 31/08/2021 H805348, exp. date 30/11/2021 H900065, exp. date 31/12/2021 H902264; exp. date 31/05/2022 b) Lot# H804082, exp. date 31/08/2021 H804121, exp. date 31/08/2021 H804338, exp. date 31/08/2021 H804538, exp. date 30/09/2021 H804539, exp. date 30/09/2021 H805349, exp. date 30/11/2021 H805350, exp. date 30/11/2021 H900066, exp. date 31/12/2021 H900067, exp. date 31/12/2021 H902265, exp. date31/05/2022 H902275, exp. date31/05/2022 H902276, exp. date31/05/2022 H902531, exp. date 30/04/2022 H902532, exp. date 30/04/2022

Distribution pattern: Product was distributed to major distributors who may have further distributed the product nationwide.