Potential presence of carcinogen: Lupin recalls Irbesartan, Irbesartan & Hydrochlorothiazide tablets

New Delhi: The US subsidiary Lupin Pharmaceuticals Inc is voluntarily recalling the batches of popular antihypertensive medicines Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level in the due to the potential presence of the carcinogen N-nitrosoirbesartan.

This move comes after Lupin's ongoing assessment, which revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan.

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

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 Irbesartan 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.

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 are packaged in 30 and 90-count bottles and 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.

Irbesartan and hydrochlorothiazide tablet USP is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, 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.

Irbesartan and hydrochlorothiazide tablets USP, 150mg/12.5mg and 300mg/12.5mg, are packaged in 30 and 90 count bottles and distributed nationwide in the US to wholesalers, drug chains, mail-order pharmacies, and supermarkets.

Lupin discontinued the marketing of Irbesartan and HCTZ Tablets on Jan 7, 2021. 

The company is also 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 is issued already in connection with the above, stating, "Wholesalers, distributors and retailers that have Irbesartan Tablets USP, 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg that are being recalled should discontinue distribution of the recalled product lots immediately and return it to Inmar Rx Solutions, Inc., 635 Vine St, Winston Salem, NC 27101. Tel: (855) 769-3988 / (855) 769-3989."

"Patients taking Irbesartan Tablets USP, 75mg, 150mg, and 300mg, as well as Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg, and 300mg/12.5mg, are advised to continue taking their medication while seeking advice from their pharmacist, physician, or medical provider about an alternative treatment" the release.added.