Drug recall D-0087-2022
Product
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
Lots and codes
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
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 134,016 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.