D-0088-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 10, 2021
- Initiation Date
- October 12, 2021
- Termination Date
- January 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 119,544 bottles
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
Distribution Pattern
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