This Medication Just Recalled Over "Cancer-Causing" Impurity, Says FDA
A blood pressure medication has just been recalled, according to the FDA, due to a cancer-causing "impurity." "Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level," says the agency. Read on to find out more about this medication recall—and to ensure your health and the health of others, don't miss these Sure Signs You've Already Had COVID.
Here's Why the Medication is Being Recalled
"As part of Lupin's ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan," the FDA wrote. "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."
The Risk Statement
Says the FDA: "N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
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 is 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 Tablets on Jan 7, 2021."
What to Do if You Have This Medication
"Patients taking, Irbesartan Tablets USP, 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment," says the FDA.
If You Need to Contact Someone….
"Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 769-3988 / (855) 769-3989 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the bottle label," says the FDA. "Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax."
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