After Europe bans irbesartan made by Aurobindo, FDA announces its recall in US

By PharmaCompass

2018-11-01

Impressions: 121 Article

Earlier this month, we had carried news on Aurobindo Pharma — on October 8, the European Directorate for the Quality of Medicines & HealthCare (EDQM) suspended Aurobindo’s CEP (Certificate of Suitability), effectively stopping the supply in the EU of medicines containing irbesartan from this company.

Irbesartan is the third sartan to be found with low levels ofN-nitrosodiethylamine (NDEA), a known animal and suspected human carcinogen. The detection of impurities – N-nitrosodimethylamine (NDMA) and NDEA – in valsartan from Zhejiang Huahai Pharmaceuticals over the last few months has led to an EU-wide review of all valsartan medicines. The review was subsequently extended to other ‘sartan’ medicines when very low levels of NDEA were found in losartan made by Hetero Labs in India.

This week, FDA alerted patients and health care professionals to ScieGen’s voluntary recall of certain lots of irbesartan because they contain NDEA. FDA laboratory testing confirmed NDEA in some lots of ScieGen’s irbesartan. ScieGen’s irbesartan products are labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc.

ScieGen’s recall affects about 1 percent of the irbesartan drug products in the US market.

Aurobindo Pharma, which manufactures the active pharmaceutical ingredient (API) for ScieGen’s irbesartan products, is recalling all unexpired lots of its irbesartan API supplied to the US market with NDEA.

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