Although there have been no reported injuries due to the pills contaminated with the sand-grain-sized glass particles, The U.S. Food and Drug Administration (FDA) reported the company would stop manufacturing the active ingredient made at one of the company’s plants in India. Earlier this month, Ranbaxy recalled 40 lots of pills that had been contaminated with glass.
According to The New York Times, the company has been operating under a court-ordered consent decree since January because of problems federal regulators found at other Ranbaxy plants in India and the United States. The decree bans Ranbaxy from producing drugs to be sold in the U.S. until the company can prove their plants meet U.S. standards. The company has also been accused of giving false data to FDA regulators.
This incident has once again raised a claxon call among experts who say that the FDA doesn’t regulate foreign drug manufacturing plants thoroughly enough. According to some studies, the FDA inspects foreign generic drug manufacturing only once every seven to 13 years. Domestic manufacturers get inspected once every two years.
One expert, who worked in the global drug manufacturing field, told The New York Times that while he was confident about the quality of drugs manufactured in the United States, “my confidence is not high when we are getting products from outside the country.”
Ranbaxy started manufacturing generic Lipitor (atorvastatin) after Pfizer lost its patent protection last November. In October, the company’s product accounted for 43 percent of overall generic Lipitor prescription sales.
It is a drug manufacturer’s responsibility to produce drugs that are free from contamination and are safe for the public. The recent nationwide fungal meningitis outbreak only confirms the need for drug manufacturers to act responsibly. If you’ve been harmed by a recalled drug, contact the pharmaceutical recall attorneys at Farah & Farah to find out what your legal options might be. We can be called at (800) 533-3555 or can be contacted online.