If you take Irbesartan Tablets or Irbesartan and Hydrochlorothiazide Tablets from Lupin Pharmaceuticals to help control your high blood pressure, listen up! Lupin has issued a voluntary recall of certain batches of this blood pressure medication due to potential cancer-causing ingredients.
The Reason For The Recall
According to the announcement from the Food and Drug Administration (FDA), Lupin Pharmaceuticals is recalling their Irbesartan Tablets and their Irbesartan and Hydrochlorothiazide Tablets at the consumer level because the company’s analysis has detected high amounts of N-nitroso irbesartan.
While testing API batches—which are product batches that aren’t finished—the company found that they were “above the specification limit for the impurity, N-nitroso irbesartan.” Based on the results from laboratory tests, this impurity is a “probable human carcinogen,” which means it’s a substance that could cause cancer.
It Can Also Be Used To Treat Other Conditions
The FDA says that the Irbesartan tablet USP is an angiotensin II receptor blocker that is used as a treatment for hypertension to lower blood pressure. It’s also used to treat diabetic nephropathy in hypertensive patients with type 2 diabetes, as well as elevated serum creatinine and proteinuria.
The Irbesartan and Hydrochlorothiazide tablet USP is a combination of irbesartan, and hydrochlorothiazide, which is a thiazide diuretic. It’s used to treat “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.”
The Recall Details
Out of an abundance of caution, Lupin has recalled all batches of Irbesartan Tablets USP—75 mg, 150 mg, and 300 mg. They also recalled all batches of Irbesartan and Hydrochlorothiazide Tablets USP—150 mg/12.5 mg and 300 mg/12.5 mg — in the United States. A complete list of product lot numbers and distribution dates can be found on the FDA website.
Both medications are packaged in 30 and 90 count bottles, and they were distributed throughout the US via wholesalers, drug chains, supermarkets, and mail order pharmacies.
Between October 8, 2018 (the earliest shipment date of the affected batches) to September 30, 2021, Lupin received four reports of illness from their Irbesartan tablets. There have been zero reports of illness from the Irbesartan and Hydrochlorothiazide (HCTZ) tablets.
Patients who are taking any of the recalled medication are advised to continue, but they should call their primary care physician, medical provider, or pharmacist to get advice on alternative treatment.
Consumers with questions should contact Inmar Rx Solutions, Inc. at (855) 769-3988 or (855) 769-3989, Monday – Friday anytime between 9:00 am and 05:00 pm (EST).