Reported Nov 10, 2021 · Terminated
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Lupin Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174
Is this the product you have?
- Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
- Lot codes and dates
a) Lot# H804310exp. date 31/08/2021 H900050exp. date 30/11/2021 H902262exp. date 31/05/2022 b) Lot# H000845exp. date 28/02/2023 H000846exp. date 28/02/2023 H000965exp. date 31/03/2023 H805345exp. date 30/11/2021 H805346exp. date 30/11/2021 H805347exp. date 30/11/2021 H805724exp. date 30/11/2021 H900061exp. date 31/12/2021 H900062exp. date 31/12/2021 H900445exp. date 31/01/2022 H901489exp. date 31/03/2022 H901490exp. date 31/03/2022 H901491exp. date 31/03/2022 H902261exp. date 31/05/2022
- Amount recalled
- 119,544 bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
This product could cause temporary or reversible health problems — stop using it.
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