Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b...
FDA Recall #D-0090-2022 — Class II — October 12, 2021
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
Reason for Recall
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
98,052 bottles
Distribution
Product was distributed to major distributors who may have further distributed the product nationwide.
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated