The expansion was announced on the U.S. Food and Drug Administration's website. The recall includes all lots of the products containing Valsartan, which is used to treat blood pressure, heart failure and reduce deaths following a heart attack.
The medication included in the recall was sold in the U.S. between March 2017 and November 2018.
The 104 additional lots include 26 lots of Amlodipine and Valsartan tablets.
These products contain trace amounts of N-nitrosodiethylamine or NDEA 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 according to the International Agency for Research on Cancer (IARC).
According to the National Institutes of Health, NDEA is a suspected human and animal carcinogen that is used in gasoline as a stabilizer for industry materials and as a lubricant additive, according to the National Institutes of Health.
Patients who take Valsartan should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan are advised to 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.
Source: wfla.com
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