USA – FDA Alerts to Recalls Over Non-Valsartan Product Found to Contain Impurities

In its latest update on the investigation into impurities detected in a growing body of sartan products, the US Food and Drug Administration (FDA) alerted to recalls initiated by two firms over the presence of the second probable human carcinogen to have been tied to the scandal.

ScieGen is recalling certain lots of its irbesartan because after finding that they contain N-Nitrosodiethylamine (NDEA), which is known animal and suspected human carcinogen, according to FDA.

“This is the first non-valsartan product the agency has found to contain the NDEA impurity” the agency said, adding that the recall “affects about 1% of the irbesartan drug products in the US market.”

The manufacturer of the active pharmaceutical ingredient (API) ScieGen used for its irbesartan products—India-based Aurobindo—is also recalling “all unexpired lots of its irbesartan API supplied to the US market with NDEA,” FDA said. This recall was initiated after laboratory testing confirmed the presence of NDEA is certain lots of Aurbindo’s irbesartan API, according to FDA.

The updates come after the European Medicines Agency (EMA) announced low levels of NDEA had been detected in Aurobindo’s irbesartan earlier this month. The move came after “very low levels of NDEA” had been detected in losartan products manufactured by the first India-based company to become involved in the scandal, Hetero Labs, prompting EMA to extend its review to cover additional sartan medicines late last month…