Teva Pharmaceuticals recalled 35 lots of bulk Losartan Potassium after a known carcinogen was discovered in the active pharmaceutical ingredient.
There has been another incident of blood pressure medications recalled due to the detection of carcinogens.
Teva Pharmaceuticals recalled 35 lots of bulk Losartan Potassium (six lots of 25 mg strength and 29 lots of 100 mg strength) after discovering the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) found in the active pharmaceutical ingredient. The impurities were found in six lots manufactured by Hetero Labs Limited, Teva said. The company said that based on available information, the risk of long-term use leading to the development of cancer cannot be ruled out. To date, Teva said it has not received any reports of adverse events related to the lots being recalled.
Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy and nephropathy in Type 2 diabetic patients. The lots were sold exclusively to Golden State Medical Supply of Camarillo, Calif. Golden State Medical Supply packages this bulk product under its own label and distributes in retail bottles of 30, 90 and 1000 tablets.
The recall is the second incident related to Hetero Labs. In March,the Food and Drug Administration (FDA) raised concerns about losartan potassium tablets sold by India-based Hetero Labs Ltd. and distributed by Camber Pharmaceuticals. Those tablets, like the ones involved in Teva’s recall, were found to have high levels of NMBA, which is a known environmental contaminant. For context, it is found in water and foods including meats, dairy products and vegetables.
This recall also marks the second recall for Teva. In November, the company issued a voluntary recall for combination forms of its blood pressure drug Amlodipine due to cancer-causing impurities. Teva said the combinations of Amlodipine, which includes Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets contained N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. Those particularly pills were manufactured in India by Mylan.
Also last fall, the FDA issued a voluntary recall for lots of Irbesartan tablets developed by N.Y.-based ScieGen Pharmaceuticals due to the presence of NDEA. Before that, in July, the FDA issued a voluntary recall of drugs that contained the active ingredient valsartan, due to the presence of NDMA. The products associated with that recall were manufactured by Zhejiang Huahai Pharmaceutical Co.
Teva said it notified Golden State Medical Supply of the presence of the impurity in the product and issued the recall. No other Teva Losartan Potassium finished drug products have been identified, in the United States, containing API above the interim specification levels set for NMBA, the company said.
The latest recall from Teva came one day after the first lawsuits were filed regarding the tainted blood pressure medications. Thousands of lawsuits could be filed against the drugmakers. The FDA has estimated that for every 8,000 people who took the highest dose of valsartan, there would be one additional case of cancer.
