ScieGen recall: US FDA finds NDEA impurity in first non-valsartan drug

Last week, active pharmaceutical ingredient (API) manufacturer Aurobindo Pharma Limited revealed that trace amounts of N-nitrosodiethylamine (NDEA) had been detected in its irbesartan drug product.

The presence of NDEA, which is classified by the International Agency for Research on Cancer​ as a probable carcinogen, prompted the Indian manufacturer to issue a voluntary nationwide recall​ of 22 batches of irbesartan on October 26, 2018.

Irbesartan is an angiotensin II receptor blocker used for the treatment of hypertension.

“These 22 batches of irbesartan drug substance were supplied to ScieGen Pharmaceuticals Inc., US, for the manufacturing of finished irbesartan drug product,” ​disclosed Aurobindo at the time.

US Food and Drug Administration (FDA) laboratory testing confirmed the presence of NDEA in some lots of ScieGen’s irbesartan.

On October 28, ScieGen also issued a voluntary nationwide recall – for the return of irbesartan tablets, USP 75mg, 150mg, and 300mg. The New York-based company highlighted that, at the time of recall, it had not received any reports of adverse events related to the product in question.

According to the FDA, ScieGen’s recall affects approximately 1% of the irbesartan drug products in the US market and, to date, the company is the only manufacturer of irbesartan finished drug products found to contain NDEA.

“We are working with our distributors and expect to receive contaminated products in the next few weeks,” ​a ScieGen spokesperson told us today.

ScieGen will continue to work with its API supplier, we were told. “Aurobindo identified the source of impurity generation and they are in the process of optimising the manufacturing process to produce API within the permissible limits of NDEA,” ​the spokesperson added.

Valsartan impurities ​

ScieGen Pharmaceuticals’ irbesartan is the first non-valsartan drug found to contain NDEA in the US.

In June this year​, the European Medicines Agency (EMA) announced that certain medicines containing valsartan, supplied by Chinese API maker Zhejiang Huahai Pharmaceuticals, contained the probable carcinogen.

Valsartan-based medicine is used to treat patients with high blood pressure.

The FDA joined the EMA in issuing nationwide recalls of certain valsartan medicines in July​, and the following month​, the Chinese government requested medical institutes return contaminated valsartan products and stop using the medicine.

Just last month​, the EMA detected low levels of NDEA in a batch of losartan containing an API from Indian manufacturer, Hetero Labs.