(NEXSTAR) – Lupin Pharmaceuticals Inc. is voluntarily recalling a blood pressure medication that possibly contains high levels of a cancer-causing impurity, according to the U.S. Food and Drug Administration.
The company is recalling its Irbesartan and Hydrochlorothiazide tablets at the consumer level after an analysis revealed that certain API batches contained the impurity N-nitrosoirbesartan — a probable human carcinogen — at levels above the specification limit.
Lupin 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 United States.
The batches of the tablets, packaged in 30- and 90-count bottles, were distributed nationwide in the United States to wholesalers, drug chains, mail-order pharmacies and supermarkets.
Lupin stopped marketing Irbesartan and Irbesartan and HCTZ tabs in January 2021. The company said it has received no reports of illness that appear to relate to this issue and is recalling the products “out of an abundance of caution.”
The pharmaceutical company is notifying its wholesalers, distributors, drug chains, mail-order pharmacies, and supermarkets by phone and through the recall notification, and is arranging for the return of all the affected products, according to the recall notice.
Patients taking the medications are advised to continue taking their medication and contact their pharmacist, physician or medical provider for advice regarding alternative treatment.