Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09)...
FDA Recall #D-0088-2022 — Class II — October 12, 2021
Product Description
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) 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
119,544 bottles
Distribution
Product was distributed to major distributors who may have further distributed the product nationwide.
Code Information
a) Lot# H804310, exp. date 31/08/2021 H900050, exp. date 30/11/2021 H902262, exp. date 31/05/2022 b) Lot# H000845, exp. date 28/02/2023 H000846, exp. date 28/02/2023 H000965, exp. date 31/03/2023 H805345, exp. date 30/11/2021 H805346, exp. date 30/11/2021 H805347, exp. date 30/11/2021 H805724, exp. date 30/11/2021 H900061, exp. date 31/12/2021 H900062, exp. date 31/12/2021 H900445, exp. date 31/01/2022 H901489, exp. date 31/03/2022 H901490, exp. date 31/03/2022 H901491, exp. date 31/03/2022 H902261, exp. date 31/05/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated