Drug recall D-0086-2022
Product
Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
Reason for recall
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Lots and codes
a) Lot# H000843, exp. date 28/02/2023 H805727, exp. date 30/11/2021 H901579, exp. date 31/03/2022 b) Lot# H000844, exp. date 28/02/2023 H000964, exp. date 31/03/2023 H804311, exp. date 31/08/2021 H805267, exp. date 30/11/2021 H805268, exp. date 30/11/2021 H805269, exp. date 30/11/2021 H805725, exp. date 30/11/2021 H805726, exp. date 30/11/2021 H901497, exp. date 31/01/2022 H901577, exp. date 31/03/2022 H901578, exp. date 31/03/2022 H902258, exp. date 31/05/2022
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 51,144 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.