Lupin, Aurobindo Pharma unit recall products from US over manufacturing issues

Eugia commenced the nationwide Class II recall on May 23 this year.

According to USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Eugia is also recalling 15,500 single-dose vials of Eptifibatide injection from the US market, the American health regulator said.

The medication prevents blood from clotting during episodes of chest pain or a heart attack.

Eugia is recalling the affected lot due to "failed impurities/ degradation specifications", USFDA said.

The company initiated the Class III recall on May 22 this year.

As per USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".

India is the largest supplier of generic medicines, with around 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.

The products manufactured in the country are shipped to over 200 countries around the globe, with Japan, Australia, Western Europe, and the US as main destinations.

India has the highest number of USFDA-compliant companies with plants outside the US.