Reported Nov 10, 2021 · Terminated
Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) 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, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
- Lot codes and dates
a) Lot# H804403exp. date 31/08/2021 H805251exp. date 30/11/2021 H805640exp. date 30/11/2021 H901580exp. date 30/04/2022 b) Lot# H804492exp. date 31/08/2021 H805252exp. date 30/11/2021 H805253exp. date30/11/2021 H805641exp. date30/11/2021 H805642exp. date30/11/2021 H805643exp. date 30/11/2021 H901581exp. date 30/04/2021 H902139exp. date 30/04/2022 H902140exp. date 30/04/2022
- Amount recalled
- 134,016 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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