FDA Updates Investigation on Valsartan Impurities, Expands Recall

FDA Commissioner Scott Gottlieb announced more recalls in the FDA’s ongoing investigation into contaminated valsartan products and said the impurity may be a byproduct of the API manufacturing process.

Gottlieb said the recalls now include five manufacturers and other companies involved in repackaging the products under different names. While more than half of all valsartan products on the market are being recalled because they contain an NDMA impurity, more products may still need to be pulled, he said.

The FDA’s ongoing investigation of Zhejiang Huahai Pharmaceuticals, a manufacturer and supplier linked to the contaminated valsartan that received two Form 483s for repeat quality deficiencies in 2016 and 2017, studied the company’s API manufacturing process and changes made to it over time.