Lupin Pharmaceuticals Recalls All Irbesartan Tablets and Irbesartan & Hydrochlorothiazide Tablets Due to the Presence of N-nitrosoirbesartan, a Known Human Carcinogen
Irbesartan Tablets
WASHINGTON, D.C. – On October 14, 2021, the U.S. Food and Drug Administration announced Lupin Pharmaceuticals, Inc. had initiated a recall of its Irbesartan plus Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg; and Irbesartan Tablets USP 75mg, 150mg, and 300mg due to N-nitrosoirbesartan contamination.
The FDA’s recall announcement states that Lupin’s ongoing product analysis discovered that certain unfinished batches were “above the specification limit for the impurity, N-nitrosoirbesartan.” Lupin reports that the company has not received any adverse medical reports concerning the N-nitrosoirbesartan issue. However, Lupin is recalling all lots of Irbesartan plus Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg and Irbesartan Tablets USP 75mg, 150mg, and 300mg distributed in the United States. Lupin has also discontinued the sale of Irbesartan and Irbesartan plus Hydrochlorothiazide tablets back in January 2021.
The FDA’s Risk Statement Concerning N-nitrosoirbesartan
According to the FDA’s announcement, N-nitrosoirbesartan is an impurity that is known as a probable human carcinogen. In other words, this impurity is linked to an increased risk of cancer. These findings were based on laboratory tests.
Lupin stated that there have been four reports of illness linked to the company’s Irbesartan tablets. There have been no reports of illnesses connected with Lupin’s Irbesartan plus Hydrochlorothiazide Tablets.
Irbesartan is an angiotensin II receptor blocker used in the treatment of hypertension. The medication treats high blood pressure and also treats diabetic nephropathy in hypertensive, type 2 diabetes patients with proteinuria and elevated serum creatinine. Irbesartan Tablets are packages in 30- and 90-count bottles and are sold in 75mg, 150mg, and 300mg strengths. Irbesartan was marketed nationwide to drug store chains, supermarkets, wholesalers, and mail-order pharmacies. On January 7, 2021, Lupin discontinued the sale of Irbesartan Tablets.
The affected lots are listed below:
Irbesartan and Hydrochlorothiazide Tablet USP combine Hydrochlorothiazide (a thiazide diuretic) with Irbesartan (an angiotensin II receptor antagonist) is used to treat hypertension in patients who have uncontrolled monotherapy or is used initially in patients who need many medications to regulate their blood pressure. Irbesartan and Hydrochlorothiazide Tablet USP, 150mg/12.5mg, and 300mg/12.5mg are also sold in 30- and 90-count bottles. The medication was sold nationwide to mail-order pharmacies, supermarkets, wholesalers, and drug chains. Lupin suspended the sale of Irbesartan and Hydrochlorothiazide Tablets on January 7, 2021.
The affected lots are in the table below:
Lupin Pharmaceuticals Inc. is contacting its distributors, wholesalers, mail-order pharmacies, drug chains, and supermarkets by telephone, recall notification, and is preparing for the return of the recalled medications.
The recall notice states that patients who are prescribed Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg and Irbesartan Tablets USP, 75mg, 150mg, and 300mg should continue taking their prescription and speak to their pharmacist and doctor for advice concerning a different treatment.
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