Torrent Pharmaceuticals Limited issued a voluntary recall of its losartan potassium and losartan potassium/hydrochlorothiazide tablets due to potentially cancer-causing impurity.
The U.S. Food and Drug Authority made the announcement on Thursday, April 18. A full list of all recalled medication is available on the federal government agency's website.
Blood Pressure Drugs Recalled
The impurity found in the active pharmaceutical ingredient, or API, is N-Methylnitrosobutyric acid or NMBA. The chemical has been tagged as a potential carcinogen to humans.
Torrent Pharmaceuticals has not received complaints of adverse side effects. However, the company has voluntarily recalled 36 additional lots of losartan potassium and 68 lots of losartan potassium/hydrochlorothiazide tablets that contain impurity levels that are higher than what the FDA considers to be the acceptable daily amount.
Losartan is commonly prescribed to patients with high blood pressure or as treatment for patients who have Type 2 diabetes experiencing nephropathy. While the recall is currently in effect, the FDA recommends that patients who have been prescribed with the affected medication to continue taking the drugs. They warned that abruptly stopping the treatment could cause more serious health concerns.
The agency encourages the public to consult with a pharmacist or a physician about alternatives before making changes to their regular treatment.
Product Recalls
This is the fourth recall issued by Torrent Pharmaceuticals since December. Two more product recalls were announced in January and March for potential cancer-causing impurity.
The recent notice from the FDA is related to the valsartan recalls that have been expanded multiple times for the past year. In July, the agency warned patients and healthcare professionals about the API which has also been found to contain NDMA, another ingredient that might cause cancer.
In September, the FDA placed the Zhejiang Huahai Pharmaceuticals on import alert "to protect U.S. patients." The Chinese company manufactured the APIs in the drugs that have been recalled in the past year due to impurities.
In November, the FDA issued warning letters to the company for failing to address the carcinogenic impurity in the APIs after a customer complained about it in 2016. The agency also found that the company deviated from good manufacturing practices that led to the formation of the impurites.
