FDA Issues Import Alert to Apotex for Products Manufactured at Bangalore Facility

By Pharma News - DCAT Publisher

April 3, 2014

FDA has issued an import alert to the generic-drug maker Apotex for products manufactured at the company's Bangalore, India facility. The import ban applies to all drugs and antibiotics, with the exception of riluzole, which is a drug used to slow the progress of amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease. FDA issued the import alert on April 1, 2014.

Import alerts are issued by FDA in response to violations of good manufacturing practice.

Source: FDA