The product contained N-nitrosoirbesartan impurity, a probable human carcinogen.
Lupin Pharmaceuticals is voluntarily recalling all batches of irbesartan tablets and irbesartan and hydrochlorothiazide tablets. Company analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan.
The company is recalling all lots of irbesartan tablets USP 75mg, 150mg and 300mg and irbesartan/hydrochlorothiazide tablets USP, 150mg/12.5mg and 300mg/12.5mg in the United States.
N-nitrosoirbesartan impurity is a probable human carcinogen based on results from laboratory tests. From Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches), to Sept. 30, 2021, Lupin received four reports of illness from irbesartan but no reports of illness from irbesartan and hydrochlorothiazide.
Irbesartan tablet is an angiotensin II receptor blocker 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 is packaged in 30 and 90 count bottles and was distributed nationwide in the United States to wholesalers.
Irbesartan and hydrochlorothiazide tablet 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. It was 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 irbesartan and rbesartan/hydrochlorothiazide in January 2021.
A list of the lots being recalled can be found here.