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Ranbaxy Recalls More Than 64,000 Bottles Of Generic Lipitor In U.S. After Reports Of a Dose Mix-Up
India-based generic-drug maker Ranbaxy Laboratories is recalling more than 64,000 bottles of the generic versions of its cholesterol-lowering drug in the country. The decision to callback follows after several media reported of a possible dose mix-up.
Ranbaxy is recalling tablets of atorvastatin calcium which is a generic name for Lipitor's active ingredient. Recently a pharmacist found a 20-milligram tablet in a sealed bottle which was marked for 10-milligram tablets.
The FDA has announced it as a Class II recall, which means that there is remote chance of severe adverse consequences or death due to the flaw in the product.
According to WSJ, the company has confirmed the recall in an emailed statement Friday.
Over the past two years, this is at least third recall for generic Lipitor.
Back in November 2012, Ranbaxy, India's biggest drug maker by revenue had to recall 480,000 bottles of the cholesterol fighter after contamination with tiny glass particles were discovered. The recall even prompted the company to suspend production. It was only last year, it was able to resume the production after fixing the problem.
In January, the company was barred by FDA from shipping to U.S. drug ingredients made a plant in Toansa, India. Ranbaxy said it was disappointed by the FDA actions and had apologized to stakeholders for the inconvenience caused by the shipment suspension, WSJ reported.
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