Sun Pharma recalls anti-depressant drug again

Second recall of the drug by Sun Pharma in last four months

Generic drug major Sun Pharmaceuticals has recalled about 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, said the US Food and Drug Administration.

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.

The Sun Pharma scrip closed at Rs 882.45, down 0.46 per cent, on the BSE on Monday.

The FDA 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.

According to analysts, the latest recall might not have a major impact but it points to the meticulous testing by the US regulator of drugs sold in America. In April, Sun recalled 200 vials of the chemotherapy drug gemcitabine in the US market, due to lack of assurance of sterility. In January, the company had pulled 2,500 bottles of its generic version of the diabetes drug, Glumetza as well.

During the post earnings call of the company’s second quarter results, the Sun Pharma management had said it was working on the observations by FDA about its Halol unit. In September, FDA conducted a surprise inspection at the unit.

In May, another manufacturing facility of Sun Pharma at Karkhadi in Gujarat, had received a warning from the FDA after investigators identified violations of current good manufacturing practices and regulations for finished pharmaceuticals.