FDA recalls from US shelves 200 vials of chemotherapy drug produced by Sun Pharmaceuticals

Washington, 24 Mar, 2015: India’s pharmaceutical woes continue, as the US Food and Drug Administration (FDA) announced this week that it was recalling 200 vials of products produced by Sun Pharmaceuticals Industries Ltd.

The news was announced via an “enforcement report” posted on the FDA’s official website, in which it states that 200 vials of a chemotherapy drug known as gemcitabine are being pulled from US shelves post-haste.

The reason for this, says the FDA, is that the vials were produced at Sun Pharma’s Caraco Pharmaceutical Laboratories Ltd. plant in Gujarat, which allegedly does not abide by FDA sterility standards. Because the FDA cannot guarantee whether or not the medicine coming out of the Gujarat plant is completely clean, the vials are no longer being sold.

“Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance,” is the official reason listed in the FDA enforcement report.

The report also points out, however, that the recall was voluntary, and that it was “firm initiated,” meaning that Sun and its Caraco subsidiary likely notified that FDA and took proper measures to institute the recall. This is a step in the right direction for ongoing dialogue between the FDA and Indian pharma companies, but is the latest incident to mar the relationship.

Back in March, Sun Pharma’s plant in Karkhadi, Gujarat was also hit with an import alert from the FDA, because of accusations that it was not up to standards set by the US federal watchdog agency. Sun said, at the time, that appropriate measures will be taken to correct the problem, although that plant’s effect on overall productivity was negligible.

The company also recently recalled more than 2,500 bottles of Glumetza, a generic diabetes drug that it produces, after it was discovered that certain seizure medications had been mixed into some bottles that were on pharmacy shelves. The reason for that, as well as several oversights at pharmaceutical manufacturing plants, is because the first company to debut a generic drug is allowed a six-month exclusivity period, which boosts revenue considerably.