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The US Food and Drug Administration (FDA) has announced plans to expand the recall of drugs used to treat high blood pressure.
In a statement issued Sept. 19, the agency said Torrent Pharmaceuticals Limited recalled several batches of Losartan potassium tablets after "traces" of N-methylnitrosobutyric acid, or NMDA, were discovered in medication. NMDA has been linked to cancer.
Losartan is used to treat high blood pressure, hypertension, nephropathy in patients with type 2 diabetes and left ventricular hypertrophy.
"The recall is expanded to include 3 additional lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium / Hydrochlorothiazide Tablets, USP," the Food Regulatory Authority said in a statement. "The impurity detected is N-methylnitrosobutyric acid (NMBA). Torrent only recalls batches of products containing losartan containing N-methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels published by the FDA. "
The FDA, however, has stated that patients should continue to take their medications because the risk of not taking them is greater than the risk of developing cancer.
"Patients should contact their pharmacist or their doctor who can inform them of an alternative treatment before returning their medication," added the agency.
The list of recalled products includes:
-13668-409-10 Losartan Potassium Tablets, USP 50 mg, 1000 Units 4DU2E009 on 12/31/2020
-13668-115-90 Losartan Potassium Tablets, USP 100 mg, 90 Units 4DU3E009 on 12/31/2020
-13668-115-10 Losartan Potassium Tablets, USP 100 mg, 1000 Units 4DU3D018 on 28/02/2021
-13668-116-90 tablets of potassium and hydrochlorothiazide losartan, USP 50 mg / 12.5 mg, 90 units BEF7D051 on 30/11/2020
-13668-118-90 Potassium Tablets and losartan hydrochlorothiazide, USP 100 mg / 25 mg, 90 units. 4P04D007 the 31/07/2020
According to the FDA, the drugs were distributed in the United States via the wholesale distributor of Torrent.
Torrent also informs its distributors by telephone and in writing of the reminder. The manufacturer also prepares the return of all recalled products to Qualanex.
Labels, photos, and other recall information are available on the FDA's Recall website.
Zantac Recall
Low levels of carcinogen have been discovered in the Zantac heartburn drug and its generic variants, according to the FDA in a statement released Sept. 14.
NDMA, or N-Nitrosodimethylamine, has been associated with an increased risk of several types of cancer.
The agency said she "learned that certain ranitidine-based medicines, including some products known as Zantac branded medication, contain" this impurity.
The chemical is found in generic versions of Zantac containing ranitidine, the agency said.
"When the agency identifies a problem, it quickly takes the appropriate steps to protect patients. The FDA is assessing whether low levels of NDMA in ranitidine pose a risk to patients. The FDA will publish this information as soon as it is available, "reads the statement.
The origin of NDMA contamination is unclear.
NDMA is the same chemical that has caused several heart and blood pressure recalls over the last year.
Zantac has not yet been reminded about the conclusion.
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