Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
This recall has been terminated (originally issued November 10, 2021).
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- October 12, 2021
- Posted
- November 10, 2021
- Recall Number
- D-0086-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 51,144 bottles
- Firm Location
- Baltimore, MD, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Distribution
Product was distributed to major distributors who may have further distributed the product nationwide.
Lot / Code Info
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