Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09)...
FDA Recall #D-0087-2022 — Class II — October 12, 2021
Product Description
Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) 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
134,016 bottles
Distribution
Product was distributed to major distributors who may have further distributed the product nationwide.
Code Information
a) Lot# H804403, exp. date 31/08/2021 H805251, exp. date 30/11/2021 H805640, exp. date 30/11/2021 H901580; exp. date 30/04/2022 b) Lot# H804492, exp. date 31/08/2021 H805252, exp. date 30/11/2021 H805253, exp. date30/11/2021 H805641, exp. date30/11/2021 H805642, exp. date30/11/2021 H805643, exp. date 30/11/2021 H901581, exp. date 30/04/2021 H902139, exp. date 30/04/2022 H902140, exp. date 30/04/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated