Community SDoH Alert!

Nationwide – BLOOD PRESSURE RECALL – Lupin Pharmaceuticals, Inc. Issues Voluntarily Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets Due to Potential Presence of – (a substance that could cause cancer) Impurity

  • Alert date October 15, 2021

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    Summary

    Company Announcement Date:
    October 14, 2021
    FDA Publish Date:
    October 14, 2021
    Product Type:
    Drugs

    Reason for Announcement:
    API batches above the specification limit for the impurity, a probable human carcinogen, (a substance that could cause cancer).

    Company Name:
    Lupin Pharmaceuticals, Inc.

    Brand Name:
    Lupin

    Product Description:
    Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg, which is a probable human carcinogen (a substance that could cause cancer).

    Risk Statement: N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

    From October 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches), to September 30, 2021, Lupin received 4 reports of illness from Irbesartan and 0 reports from Irbesartan and Hydrochlorothiazide.

    Irbesartan tablet USP is an angiotensin II receptor blocker indicated for treatment of hypertension, to lower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. Irbesartan Tablets USP 75mg, 150mg and 300mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan Tablets on Jan 7, 2021.

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