ScieGen Recalls Sartan Product Due to Impurity in API

By Akia Thorpe -

November 9, 2018

ScieGen Pharmaceuticals, a Hauppauge, New York-based generic pharmaceutical company, is voluntarily recalling in the US lots of its irbesartan tablets (USP 75 mg, 150 mg, and 300 mg), an anti-hypertension drug, to the consumer level. The recall is due to the presence of a probable human carcinogen, N-nitrosodiethylamine (NDEA), found in irbesartan manufactured and supplied by Aurobindo Pharma, a Hyderabad, India-headquartered generics and active pharmaceutical ingredient (API) manufacturer. Irbesartan is the third “sartan” API, which has been subject to impurity concerns in the industry; valsartan and lorsartan are the other two. These APIs are used in ant-hypertensive drugs.

Aurobindo reported that it supplied 22 batches of the irbesartan drug substance to ScieGen for the manufacturing of the finished irbesartan drug product. ScieGen’s recall was triggered as a result of Aurobindo Pharma finding an NDEA impurity in its irbesartan API in October 2018. At the time of the recall, ScieGen Pharmaceuticals reported that it had not received any reports of adverse events related to the product.

Irbesartan is the third “sartan” in which a probable human carcinogen was found by regulatory agencies. The FDA and European Medicines Agency began their initial investigation into the “sartans” after the EMA learned that Zhejiang Huahai Pharmaceuticals (ZHP), a Linhai, China-based pharmaceutical company, had detected N-nitrosodimethylamine (NDMA) and NDEA, two probable human carcinogens, in several batches of its valsartan API. The FDA’s investigation began when a manufacturer of valsartan products detected NDMA in its API supplied from Zhejiang Huahai Pharmaceuticals, which followed with other companies recalling valsartan products. The EU’s detection of the two impurities led to an EU-wide review of all valsartan medicines marketed in the EU. The review was subsequently extended to other “sartan” medicines when very low levels of NDEA were found in losartan made by Hetero Labs, a Hyderabad, India-headquartered pharmaceutical company. In October 2018, the EMA updated that it was evaluating the APIs, candesartan, irbesartan, losartan, and Olmesartan marketed in the EU in addition to its investigation into valsartan products. After low levels of NDEA were found in irbesartan, made by Aurobindo Pharma, the FDA expanded its investigation to include both valsartan and irbesartan. ScieGen Pharmaceuticals’ irbesartan is the first API outside of valsartan products to be found contaminated by NDEA for products marketed in the US.

Source: ScieGen Pharmaceuticals and FDA