On Friday, Teva Pharmaceuticals announced it has initiated a voluntary recall of 35 lots of its Losartan Potassium USP Tablets. Of those, 29 lots are 100mg strength while six lots are 25mg strength.
Company officials said the recall was due to the detection of an impurity of an active pharmaceutical ingredient.
On Thursday, Torrent Pharmaceuticals Limited told the Food and Drug Administration (FDA) it was recalling an additional 36 lots of its Losartan Potassium Tablets USP and an additional 68 lots of Losartan Potassium/hydrochlorothiazide tablets USP.
The company said it was expanding the recall to “the consumer level” because of the discovery of trace amounts of the same impurity.
This was the fourth recall since December of blood pressure medications manufactured by Torrent Pharmaceuticals.
It’s also the latest in a long line of blood pressure medications that have been recalled since late July due to the detection in the products of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), which has been classified as a potential cancer-causing substance.
In late February, Camber Pharmaceuticals informed FDA officials that it was recalling 87 lots of 25mg, 50mg and 100mg Losartan tablets.
The week before, Macleods Pharmaceuticals Limited informed the FDA that it was voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide 100mg/25mg combination tablets.
Macleods officials said they detected trace amounts of an impurity called N-nitrosodiethylamine (NDEA), another pharmaceutical ingredient the FDA has classified as a “probable human carcinogen.”
The Losartan tablets are used to treat hypertension and hypertensive patients with left ventricular hypertrophy.