According to the press release, the drugs contain too much N-nitroso-diethylamine (NDEA), a chemical manufactured in Mylan, India. The key ingredient, typically found in certain foods, drinking water and air pollution, has been classified as a human carcinogen by the International Agency for Research on Cancer.
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Teva noted it has not received any reports of illness, but it has asked its retailers to stop distributing the products and to return them immediately.
Patients on the medications are advised to continue taking the tablets and to contact their doctor for advice for alternate treatments. The company said, “the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any comparable alternative treatment.”
The agency recently recalled three other blood pressure medications due to cancer concerns, and another was recalled for mislabeling.
Read the full FDA announcement at FDA.gov.