Recalls / Class II
Class IID-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
- Brand name
- Irbesartan
- Generic name
- Irbesartan
- Active ingredient
- Irbesartan
- Route
- Oral
- NDCs
- 68180-411, 68180-410, 68180-412
- FDA application
- ANDA201531
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 119,544 bottles
- Distribution pattern
- Product was distributed to major distributors who may have further distributed the product nationwide.
Timeline
- Recall initiated
- 2021-10-12
- FDA classified
- 2021-11-01
- Posted by FDA
- 2021-11-10
- Terminated
- 2023-01-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0088-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.