Torrent Pharmaceuticals Limited Issue Voluntary Recall of Valsartan / Amlodipine / HCTZ Tablets
The Food and Drug Administration has reported that Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan / Amlodipine / HCTZ Tablets.
This recall is due to the detection of trace amounts of an impurity found in an active pharmaceutical ingredient (API). These products are manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected is NDMA, or N-nitrosodimethylamine. This substance is often found in water, air pollution and certain foods.
NDMA is an impurity and is a probable human carcinogen classified by the International Agency for Research on Cancer. Numerous animal trial studies show that exposure to the organic compound can lead to tumors in the respiratory tract, liver, and kidney. Taking a product containing NDMA can increase your risk for cancer. 22 other countries have issued a recall, including Germany, Norway, Austria, Spain, and Canada.
Valsartan is part of various medications used to treat high blood pressure, heart failure, and other cardiovascular issues. The FDA has not received any reports of adverse side effects related to the recall. Those taking the drug should consult their doctor or pharmacist, and to continue taking it as prescribed.
Not all drugs containing valsartan are included in the recall. For a complete list, visit The Food and Drug Administrations website. The recall does not include any Novartis or Sandoz products.
The FDA has also reported that several other companies that repackage drug products are also recalling valsartan-containing products. There are three additional repackagers of valsartan-containing products made by Teva Pharmaceuticals and Prinston Pharmaceuticals Inc. – labeled as A-S Medication Solutions LLC, AvKARE and RemedyRepack.
Symptoms of overexposure to NDMA include fever, headaches, nausea, vomiting, abdominal cramps, kidney and lung issues, and enlarged liver.