If You Take This Common Medication, Call Your Doctor Now, FDA Says
It may be contaminated with a potential carcinogen, experts warn.
You may know what your medications are prescribed to treat, but for many people, the mechanism by which those drugs work isn't always clear. And while the label on your prescription bottles may give you some indication as to what's contained in those medications, there may be a number of ingredients whose purpose you're not as familiar with. Unfortunately, in the case of one common medication, what you don't know could hurt you, as it's now being pulled from the market for contamination with a potential carcinogen. Read on to discover which medication is being recalled and what to do if you have it at home.
Lupin Pharmaceuticals, Inc. is recalling two blood pressure medications.
On Oct. 14, the FDA announced that Baltimore, Maryland-based Lupin Pharmaceuticals Inc. had voluntarily recalled select batches of its Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets USP, medications commonly used to control high blood pressure.
The affected medications include 75-mg. Irbesartan Tablets USP with NDC numbers 68180-410-06 and 68180-410-09, 150-mg. Irbesartan Tablets USP with NDC numbers 68180-411-06 and 68180-411-09, and 300-mg. Irbesartan Tablets USP with NDC numbers 68180-412-06 and 68180-412-09, all of which were distributed on Oct. 10, 2018 and Dec. 3, 2020. The recall also affects 150-mg./12.5-mg. Irbesartan and Hydrochlorothiazide Tablets USP with NDC numbers 68180-413-06 and 68180-413-09 and 300-mg./12.5-mg. Irbesartan and Hydrochlorothiazide Tablets USP with NDC numbers 68180-414-06 and 68180-414-09, both of which were distributed on Oct. 17, 2018 and Nov. 18, 2020. The medications were made available to consumers through drugstores, supermarkets, wholesalers, and mail-order pharmacies.
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The medications could be contaminated with a potential carcinogen.
The recall was initiated after it was discovered that the medications may have levels of N-nitroso irbesartan that exceed acceptable limits for human consumption.
"N-nitroso irbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests," the recall notice explains.
The medications have been associated with multiple illnesses.
Between Oct. 8, 2018 and Sept. 30, 2021, Lupin Pharmaceuticals received four reports of individuals becoming ill after taking Irbesartan and no reported illnesses associated with Irbesartan and Hydrochlorothiazide.
Lupin Pharmaceuticals has not marketed either medication since Jan. 17, 2021 and is notifying distributors of both medications about the recall and coordinating the return of the affected prescriptions.
If you take either medication, call your doctor.
Despite the potential impurity, individuals prescribed the recalled medications are advised to continue taking them until a healthcare professional can implement an alternate treatment plan.
If you have questions related to the recall, contact Inmar Rx Solutions, Inc. at (855) 769-3988 or (855) 769-3989 on weekdays from 9 a.m. to 5 p.m. The recalled medications can also be returned to Inmar Rx Solutions for a refund.