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Lupin Pharmaceuticals, Inc. issues Voluntarily Nationwide Recall of all Irbesartan Tablets and Irbesartan and Hydrochlorothlazide Tablets



Posted On : 2021-10-14 17:56:29( TIMEZONE : IST )

Lupin Pharmaceuticals, Inc. issues Voluntarily Nationwide Recall of all Irbesartan Tablets and Irbesartan and Hydrochlorothlazide Tablets

Lupin Pharmaceuticals Inc. is voluntarily recalling selected batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin's ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosolrbesartan. Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of lrbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg / 12.5mg and 300mg / 12.5mg in the US.

Lupin discontinued the marketing of Irbesartan and Irbesartan and HCTZ tabs in Jan 2021.

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 lrbesartan and Hydrochlorothiazide.

lrbesartan tablet USP is an angiotensin II receptor blocker indicated for treatment of hypertension, to tower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and protelnuria. lrbesartan 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 lrbesartan Tablets on Jan 7, 2021.

Shares of Lupin Limited was last trading in BSE at Rs. 946.10 as compared to the previous close of Rs. 963.50. The total number of shares traded during the day was 100626 in over 5033 trades.

The stock hit an intraday high of Rs. 968.30 and intraday low of 945.00. The net turnover during the day was Rs. 96211541.00.

Source : Equity Bulls

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Lupin LupinPharmaceuticalsInc VoluntaryRecall INE326A01037