The affected lot has been produced in India and is being recalled by New Jersey-based Glenmark Pharmaceuticals Inc for “failed dissolution specifications”, the USFDA said.
“Out of Specification (OOS) was reported in a test of dissolution at the 12th month time point in long-term stability study,” it noted.
Glenmark initiated Class II recall of the drug across the US on March 26 this year.
As per the 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.
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, West Europe and the US as the main destinations.
India has the highest number of USFDA-compliant companies with plants outside of the US.
