Sun Pharmaceuticals Industries has recalled around 68,000 bottles of its anti-depressant venlafaxine hydrochloride from the US market. The company withdrew the drugs, manufactured in its Halol unit in India, after they failed to dissolve properly.
The USFDA has called it a Class II recall, which means use or exposure to the drug would cause temporary or medically reversible adverse health consequences. Dissolution tests are a standard practice to check how a drug performs inside a body.
This is the second recall of this drug by Sun Pharma in last four months. In July, the company had recalled about 40,000 bottles. Sun Pharma Global Inc, Dubai, United Arab Emirates, started the recall on September 26.
Sun Pharma is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.