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

fda
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. 

Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This on-demand webinar discusses the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

RELATED: FDA finds more impurities in recalled high blood pressure drug valsartan

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.

Suggested Articles

Teva will produce its new migraine drug at a plant in Israel and more news of note.

The shortage of childhood cancer drug vincristine was front and center during the Senate hearing for Stephen Hahn, nominee for FDA commissioner.

The FDA has lambasted the Torrent Pharmaceuticals in a warning letter for making OTC meds using water tainted with bacteria.