The manufacturer of a generic version of the cholesterol drug Lipitor has recalled scores of the pills this month because they contain tiny particles of glass, according to U.S. regulators. The recall is the latest in a string of products liability incidents that have caused American agencies to prohibit the import of medication from Ranbaxy Pharmaceuticals, a drug manufacturer based in India.
The company confirms that it is recalling 10-, 20- and 40-milligram tablets because of the potential contamination. Lipitor is one of the world’s top-selling drugs, according to media reports, so the impact of these claims could be staggering if consumers actually ingest the drugs. The recall includes 41 lots with as many as 500 pills per bottle, according to company representatives.
Statements from company leaders indicate that the manufacturer will conduct a two-week internal investigation. They released a statement to the media explaining that they expect shipments to America to resume shortly after the investigation is complete. Federal regulators have not confirmed that assertion, however. Considering Ranbaxy’s history with pharmaceutical problems, the company’s ability to export to the U.S. could be suspended for some time.
Manufacturing deficiencies at the company’s plants date back more than six years, when a series of investigations showed that the firm did not properly determine the shelf life of its drugs. Another 2008 sanction prohibited the company from distributing more than 30 different pharmaceutical products manufactured at plants throughout India. The company was accused of falsifying testing documents to allow faulty medications to pass through their screening process.
Ranbaxy also produces the generic Lipitor at a plant in New Jersey. Investigators are not sure whether the faulty pills were made in India and shipped to the U.S., or if they were created at the American-based plant.
Patients who have experienced health problems because of these generic Lipitor pills may have legal recourse. Those who have sustained injury could sue Ranbaxy for compensatory damages for medical bills associated with their ailments. They could also seek funds for pain and suffering if they become ill from taking the Lipitor.
Source: Yahoo! News, “Ranbaxy recalls generic Lipitor doses,” Linda A. Johnson, Nov. 26, 2012.