Aurobindo Pharma USA, Inc. is recalling 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP. A full list of the recalled drugs and medication packaging can be found in the Food and Drug Administration’s website.
The impurity in the product is N-nitrosodiethylamine (NDEA), a substance that naturally occurs in some food, drinking water, air pollution and industrial processes. The FDA says the detected quantities are above the acceptable limit, classifying it as a probable human carcinogen.
The FDA recommends those who take the recalled drugs should not stop taking the medication, but should contact their pharmacist or doctor to set up an alternative treatment.
“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.
The company says it has not received any reports of adverse effects related to the recall.
To report an adverse event or to contact the drug manufacturer about questions regarding the recall, consumers should call 1-866-850-2876 and press option two or email pvg@aurobindousa.com.
Adverse reactions to the medication can also be reported to the FDA.
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