Recalls / Class II
Class IID-0089-2022
Product
Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
- Affected lot / code info
- a) Lot# H804537, exp. date 30/09/2021 H805148, exp. date 31/10/2021 H900063, exp. date 31/10/2021 H900522, exp. date 31/12/2021 H901582, exp. date 31/01/2022 b) Lot# H000963, exp. date 30/04/2022 H804507, exp. date 30/04/2022 H804536, exp. date 30/09/2021 H805070, exp. date 31/10/2021 H805149, exp. date 31/10/2021 H900064, exp. date 31/12/2021 H900523, exp. date 31/01/2022 H901583, exp. date 30/04/2022 H902530, exp. date 30/04/2022
Why it was recalled
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Recalling firm
- Firm
- 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
- 63,408 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-0089-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.