Recalls / Class II
Class IID-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
- 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# 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
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
- 134,016 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-0087-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.