FDA Expands Recall of Valsartan, Including Torrent Pharmaceuticals

Made-in-China blood pressure and heart drug has cancer-causing ingredient

The U.S. Food and Drug Administration (FDA) expanded its recall of a common Chinese-manufactured blood pressure and heart drug after a cancer-causing ingredient was found.

On Aug. 17, the FDA said that India-based Torrent Pharmaceuticals Limited announced that it “is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals,” which is based in China.

Torrent said that it hasn’t received any reports of adverse effects linked to the recall of the drug.

A list of the drugs included in the latest recall can be found on the FDA’s website. A report on a prior expansion of the valsartan-containing drug recall can be found here.

“Valsartan is used to control high blood pressure and for the treatment of heart failure. In combination with amlodipine plus hydrochlorothiazide, it is used to control high blood pressure. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment,” said the FDA.

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The agency added, “The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.”

If one has any medical questions or concerns about the recall or if one has to report an adverse reaction, call Torrent Pharmaceuticals at 800-912-9561 or [email protected]. Adverse reactions should be reported to a doctor.

Health Canada also recalled eight more blood pressure medications with valsartan due to the cancer-causing ingredient, Global News reported Aug. 20. The impurity was found in Teva Canada products. A full list of the recalled medications can be found on Health Canada’s website.

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The original recall for valsartan-containing drugs was announced by the FDA one month ago on July 13 after tests revealed that the carcinogen had been found in the drug.

The Epoch Times has previously reported that the majority of the valsartan-containing drugs were manufactured by Zhejiang Huahai Pharmaceuticals in Linhai, China.

NDMA, according to the Environmental Protection Agency (EPA), was once used to make rocket fuel, antioxidants, and softeners for copolymers. It isn’t used for anything other than for research.

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And the Chinese regime’s National Health Commission said that the recalled drug, which is used to treat patients with high blood pressure, shouldn’t be used for the diagnosis and treatment of diseases, Reuters reported on July 30.

“There is a lack of trust in medicines made in China now,” Rosemary Gibson, a senior adviser at The Hastings Center and an author of several books on health care issues, told The Epoch Times last month about the recall.

“The public wants their medicine to be safe. This carcinogen hidden in valsartan raises the question whether other products that are made in China have been made contrary to the global standard we came to accept.”