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Torrent Pharmaceuticals is recalling an additional 36 lots of Losartan potassium tablets and 68 lots Losartan potassium/hydrochlorothiazide tablets. This is the fourth expansion of the original recall posted in December 2018 of blood pressure medications manufactured by the company.
These medicines are being recalled due to the presence of N-Nitrosodiethylamine (NDEA) or N-Nitrosodimethylamine (NDMA). Both of these are industrial contaminants and are on lists of chemicals suspected to cause cancer. An impurity has been found in certain batches of the medications; not all are on the recall list.
According to Dr. Victoria Shin, a cardiologist with Torrance Memorial Medical Center in California, the problem isn’t the drug. “It’s a contaminant that was included in the manufacturing process that’s the problem. Patients shouldn’t lose faith in the drug itself.”
Torrent Pharmaceuticals is not aware of any incidents or illnesses related to the recall.
Losartan is prescribed for patients with high blood pressure and for Type 2 diabetics who have nephropathy.
The FDA issued a recall of certain lots of angiotensin II receptor blocker (ARB) high blood pressure medications that contain valsartan, losartan or irbesartan. For a list of the drugs recalled, visit the FDA site. The impurity level in these tablets is above what the FDA considers an acceptable daily intake level.
The FDA has developed a list of questions and answers about the drug and the recall. You’ll also find additional resources from the FDA as well.
The FDA said in a statement that it is investigating how much of the contaminants were present in the recalled drugs and is assessing what effect this might have on patients who had been taking the medications.
Not all valsartan, losartan, irbesartan-containing medications are affected and being recalled.
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