Over 64,000 bottles of the generic version of Lipitor were recalled from the US market by India-based Ranbaxy Laboratories, Reuters reported.
According to an advisory on the website of the US Food and Drug Administration, the recall came after a pharmacist discovered that a 20-milligram tablet for the cholesterol fighting drug atorvastatin calcium was found in a sealed bottle labeled for 10-milligram tablets. This is the latest challenge faced by the Indian drugmaker that had been the subject of regulatory censures because of quality issues, the report said.
The largest drug manufacturer in India in terms of revenue, Ranbaxy said that certain batches of the said drug were indeed recalled but was quick to add that they did not get any complaints about the product. In a statement it gave to Reuters, Ranbaxy said, "Ranbaxy is proactively recalling the lots out of an abundance of caution, keeping the safety of its patients in mind and with the full knowledge of the U.S. FDA."
While the US remains its largest market, Ranbaxy's factories in India cannot anymore send medicines and pharmaceutical ingredients there. The decision to ban its facility in Toansa from shipping these drugs and ingredients was imposed last month after the FDA found that the plant followed poor manufacturing practices. The same action had already been imposed previously in its other plants in 2008 and last year. Now, only Ohm Laboratories Inc, the New Jersey-based drugmaker that it owns, is allowed to make drugs that can be sold to the US. Japan's Daiichi Sankyo Co Ltd is the majority owner of Ranbaxy, the report said.
Although the recall of Ranbaxy's version of Lipitor is labeled as Class II by the FDA, which shows that there is a very slim probability of severe consequences or death because of a defect in the drug, this is not Ranbaxy's first time to pull a drug out of the market. The company also recalled various batches of another medicine that lowers cholesterol levels in November 2012 when it found that these were sullied with minute particles of glass.
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