Drug recall D-0088-2022
Product
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
Lots and codes
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
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 119,544 bottles
- Distribution
- Product was distributed to major distributors who may have further distributed the product nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 12, 2021
- Terminated
- January 30, 2023
Related products
- Irbesartan – drug information
- NDC 68180-412 Irbesartan · Irbesartan 300 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-411 Irbesartan · Irbesartan 150 mg/1 · Lupin Pharmaceuticals, Inc.