The impurity N-Nitrosodiethylamine (NDEA) was detected in quantities above the acceptable limit in certain tablets containing valsartan, the FDA said. (Fox 5 DC)
A U.S. unit of Indian generic drugmaker Aurobindo Pharma Ltd will recall 80 lots of medicines containing blood pressure drug valsartan that were found to have a probable cancer-causing impurity, according to the U.S. Food and Drug Administration.
The impurity N-Nitrosodiethylamine (NDEA) was detected in quantities above the acceptable limit in certain tablets containing valsartan, the FDA said.
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The announcement comes a month after Mylan NV said it will recall all lots of its blood pressure medicines containing valsartan, an angiotensin II receptor blocker, after global health authorities clamped down on the drug.
The health regulator said it will continue to investigate and test all angiotensin II receptor blockers for the presence of NDEA and another probable carcinogen N-nitrosodimethylamine.
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In October last year, the FDA halted imports of drug ingredients or medicines containing ingredients produced at a factory of a Chinese bulk manufacturer of valsartan, Zhejiang Huahai Pharmaceuticals.