 "Lupin")
Drug firm Lupin on Thursday said its US-based arm is voluntarily recalling all batches of two hypertension drugs due to potential presence of a substance that could cause cancer.
The company in a statement said that Lupin Pharmaceuticals Inc is voluntarily recalling lrbesartan tablets and lrbesartan and Hydrochlorothiazide tablets to the consumer level.
The tablets have been recalled due to potential presence of N-nitrosoirbesartan impurity, a substance that could cause cancer.
"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-nitrosoirbesartan," it added.
Although the company has received no reports of illness that appear to relate to this issue, out of an abundance of caution it is recalling all batches of lrbesartan tablets USP 75mg, 150mg and 300mg and lrbesartan and Hydrochlorothiazide tablets USP, 150mg/12.Smg and 300mg/12.5mg in the US, Lupin Pharmaceuticals Inc said.
Also Read
The company discontinued the marketing of lrbesartan and lrbesartan and HCTZ tabs in January 2021, it added.
"N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests," the statement said.
lrbesartan tablet USP is indicated for the treatment of hypertension, to tower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes, it added.
lrbesartan and hydrochlorothiazide tablet USP are indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals, Lupin Pharmaceuticals Inc said.
The tablets were distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets, it added.
"Lupin Pharmaceuticals Inc. 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," the statement said.
Patients taking the tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment, it added.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mall or by fax, Lupin Pharmaceuticals Inc said.
Shares of Lupin Ltd closed at Rs 946.10 on BSE, down 1.81 per cent from the previous close.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
