FDA calls down on Sun pharma over delayed follow up of recalled drugs
Saturday, October 11, 2014
The much talked about Indian pharmaceutical company, Sun pharma has been called down by the USFDA for being abstracted in following-up corrective actions for the drugs it recalled from the US market.
The company, earlier this year, recalled its diabetes drug- Metformin extended release for which the company has not put forward a proper follow-up plan. The issue was noted after USFDA investigating team inspected the company’s plant in Halol, Gujrat. The inspection raised concerns over the period of inspection.
The company failed in the requisite measures despite telling the US government that "all the (corrective) actions (related to Metformin drug recall) have been implemented", the investigators added.
Also, the company did not put forward any official corrective plans for anxiety drug Venlafaxine Hydrochloride extended release tablets, for which it initiated a recall four months ago, the inspectors noted.
