Indian generic drugmaker Ranbaxy Laboratories
Earlier this month, Ranbaxy recalled certain lots of the widely used cholesterol lowering medicine known generically as atorvastatin at doses of 10 milligrams, 20 mg and 40 mg after the company discovered contamination with tiny glass particles.
There have so far been no reports of patients being harmed due to the glass particulates, the FDA said.
The agency said it does not anticipate drug shortages due to the recall as several other companies also produce generic Lipitor, while Pfizer still sells its branded version.
FDA said it was monitoring the situation and working with other manufacturers to ensure adequate supply in order to avoid shortages of atorvastatin as a result of the recall.
During its first six months on the market, when it enjoyed marketing exclusivity, atorvastatin generated sales of nearly $600 million for Ranbaxy, according to Bhagwan Singh Chaudhary, a research associate at the brokerage IndiaNivesh
FDA said it will continue to oversee the recall process and work with the Ranbaxy to resolve pharmaceutical quality issues.
The recall is the latest in a series of manufacturing problems at Ranbaxy, which is operating under heightened scrutiny due to past problems that nearly derailed it ability to sell atorvastatin in the United States.
In 2008, the FDA banned the company from importing about 30 drugs after it found manufacturing deficiencies at two of the company's facilities in India, and Ranbaxy was later accused of falsifying data used in drug applications.
Under a proposed settlement earlier this year, Ranbaxy agreed to engage a third party to conduct a review of its facilities, implement procedures to ensure data integrity in its marketing applications, and ensure it meets good manufacturing practices.