Lupin declines after issuing voluntarily recall of hypertension treatment tablets

Lupin slipped 0.54% to Rs 941 after the company said its US based subsidiary is voluntarily recalling the batches of Irbesartan tablets and Irbesartan and Hydrochlorothiazide tablets to the consumer level.

Lupin's assessment revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity N-nitrosoirbesartan. Although Lupin has received no reports of illness, the company said it is recalling all batches out of an abundance of caution.

N-nitrosoirbesartan impurity is a probable human carcinogen {a substance that could cause cancer) based on results from laboratory tests. Lupin said it discontinued the marketing of lrbesartan and lrbesartan and HCTZ tabs in Jan 2021

 

Irbesartan tablet is an angiotensin II receptor blocker indicated for treatment of hypertension, to lower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes. Irbesartan tablets is packaged in 30 and 90 count bottles and distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets.

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

Lupin Pharmaceuticals Inc said it is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APis in over 100 markets. On a consolidated basis, the drug major's net profit soared 404.30% to Rs 548.16 crore on 22.2% jump in net sales to Rs 4,237.39 crore in Q1 FY22 over Q1 FY21.

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