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Ranbaxy faces a class action lawsuit over its recently recalled generic Lipitor medication, which was removed from the market last month after it was discovered that glass fragments may have contaminated the medication during manufacturing.
The generic Lipitor class action lawsuit (PDF) was filed in the U.S. District Court for the District of New Jersey by Francis Fenwick on November 29, seeking to represent anyone who purchased Ranbaxy’s generic atorvastatin.
Ranbaxy recalled their generic Lipitor only one day before the complaint was filed.
Although the manufacturer indicates that there have been no reports of illness or injury linked to the medication, small glass particles that are less than 1mm in size may pose a risk for consumers. Parts of a missing glass shield at the company’s India facility are suspected of being the source of the fragments.
Due to manufacturing problems, Ranbaxy has only been allowed to sell generic Lipitor in the United States, after the FDA banned about 30 of its drugs from the market in this country amid a number of manufacturing problems
The generic drug maker has also been accused of faking data sent to the FDA. The agency and Ranbaxy reached a consent decree in January, which requires the company to rehabilitate its manufacturing processes until they meet FDA standards.
Lipitor (Atorvastatin) was first approved by the FDA in December 1996 for use in lowering cholesterol. It is a member of a class of drugs called statins and works by inhibiting an enzyme in the liver that takes part in cholesterol production.
The lawsuit alleges that Ranbaxy has not done enough to warn consumers about the dangers of the glass fragments in the recalled Lipitor equivalent.
“The notice on the defendants’ website concerning the limited, retail level only recall did not offer a refund to consumers and did not provide any way for consumers to obtain information about the tainted product, the dangers involved with it, the dangers of ingestion of it, and other related issues,” the lawsuit states.
The lawsuit seeks a refund and damages payments for anyone who got the recalled drug, fines that would prevent Ranbaxy from profiting from the recalled products, an injunction against future sales of Ranbaxy generic atorvastatin, and punitive damages.