Canadian generics maker Apotex is recalling tens of thousands of bottles of a blood pressure medication manufactured at a plant in India which the FDA banned after discovering it had been faking test data for years.
According to four notices in the most recent FDA Enforcement Report, Apotex is recalling 65,442 bottles of candesartan cilexetil made at the company's plant in Bangalore after testing found they contained excessive levels of impurities. The FDA banned the plant in April. After looking over the FDA's information, Health Canada followed the FDA lead by banning more than two dozen drugs made by Apotex at the Bangalore facility.
In a warning letter, the FDA said among other things, the company had deleted data of failed test results and then reported that the batches had passed. Apotex told the FDA that the problem occurred because some employees were not following procedures but the FDA pointed out Apotex had been caught doing the same thing during two previous inspections, in 2006 and 2010.
The drugmaker has said it is working to resolve the issues and has hired outside consultants to help it bring the standards at the plant up to FDA expectations.
Apotex has a history of non-compliance. The FDA banned products from plants in Toronto and Quebec from 2009 to 2011. Apotex later sued the agency through the North American Free Trade Act for disrupting its business. In August a NAFTA tribunal found in favor of the U.S. After the bans were lifted, the agency returned for inspections and issues warning letters against the plants again.
- the notices can be found here, here, here and here