Business

Lupin recalls all Irbesartan tablet batches in US due to impurity

Drug firm Lupin on Thursday announced that it has voluntarily recalled all batches of Irbesartan tablets and lrbesartan and Hydrochlorothiazide tablets in the US due to an impurity. 

“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,” the company said in a statement. 

To be sure, N-nitrosoirbesartan impurity is a probable human carcinogen {a substance that could cause cancer) based on results from laboratory tests. 

The company further stated that 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 lrbesartan and zero reports from lrbesartan and Hydrochlorothiazide.

“Patients taking, lrbesartan Tablets USP, 75mg, 150mg and 300mg and lrbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment,” Lupin added.

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 is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets.

Shares of Lupin on BSE traded 1.81% lower at ₹946.10 apiece on Thursday. 

Meanwhile, Bloomberg earlier reported that over the past three years, millions of blood pressure pills that contain a probable carcinogen have been recalled around the world. As pharmaceutical companies have worked on finding a fix, they’ve discovered an entirely new problem: Another potentially dangerous chemical is showing up in the same drugs.

The new chemicals are called azido impurities and regulatory authorities say they’re mutagenic, meaning they can change someone’s DNA and potentially increase cancer risk.

The impurities were found in blood pressure drugs which have been recalled in Canada as well as Europe earlier this year. U.S. officials helped lead the way in the 2018 recalls of the same type of drugs tainted with the probable carcinogen N-Nitrosodimethylamine, or NDMA, though they have yet to pull any for containing the azido impurities.

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