“FDA is working with drug manufacturers to ensure future valsartan active pharmaceutical ingredients (APIs) are not at risk of NDMA formation. The agency reminds manufacturers to thoroughly evaluate their API manufacturing processes, and changes to those processes, to detect any unsafe impurities,” said the FDA in a statement.
“If a manufacturer detects new or higher levels of impurity, they should take action to prevent changes to the product’s safety profile.”
The FDA said patients with the recalled products should contact their doctor and their pharmacist if their medication is included on the recall list.
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