India’s biggest drugmaker, Ranbaxy Laboratories Ltd., is recalling 41 lots of its generic version of Lipitor from the US market because some batches may contain glass particles, the Wall Street Journal reported.
The company’s pulled 10-, 20- and 40-milligram doses of atorvastatin calcium tablets off the shelves, but will continue to ship 80-milligram tablets, according to the Associated Press.
Ranbaxy said it expected to resume shipments of the recalled doses within two weeks, after it completes an investigation of the quality lapse, the Wall Street Journal reported.
Ranbaxy has run into trouble with the US Food and Drug Admin. before for lying about the shelf life and other safety issues of its drugs, the AP reported.
The company signed a consent decree with the FDA in Dec. 2011, promising to improve manufacturing procedures and the accuracy of its data and submit to additional oversight by an independent third party for five years, the AP reported.
Ranbaxy was the first manufacturer to offer a generic version of the cholesterol-lowering drug when the US patent for Lipitor expired last Nov. 30, according to the AP.
Currently, Ranbaxy supplies generic Lipitor to some 44 percent of all Lipitor consumers – patients taking branded or generic medication – and its recall will likely lead to a shortage of the drug, according to the Wall Street Journal.
"We are doing everything we can to mitigate a shortage, including reaching out to other manufacturers," Sarah Clark-Lynn, an FDA spokeswoman, told the Wall Street Journal. "We're monitoring the situation."
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