Some irbesartan tablets in U.S. contain impurity, FDA warns

Some tablets of hypertension drug irbesartan are being recalled nationwide. (FiercePharma)

The FDA says a probable cancer-causing ingredient has been found in yet another blood pressure treatment in the U.S., leading to a nationwide recall.

The agency said on Wednesday that Hauppauge, New York-based ScieGen Pharmaceuticals is voluntarily recalling to the consumer level all lots of unexpired irbesartan tablets after they were found to contain the impurity, N-nitrosodiethylamine (NDEA).

The tablets, which were produced with an API from India’s Aurobindo, are labeled as Westminster Pharmaceuticals and Golden State Medical Supply. Consumers should return them to their pharmacies. 


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The latest discovery is part of a much larger problem that was uncovered last summer when NDEA was found in the valsartan API of China’s Zhejiang Huahai Pharmaceutical. It has been cited by the FDA in a Form 483 and its valsartan APIs have been banned in the U.S. and Europe.  

The discovery of the tainted valsartan has led to lawsuits against Huahai in Missouri, New Jersey, Illinois and New York, with allegations including gross negligence, fraudulent concealment, breach of contract and unjust enrichment.