The lawsuit was filed on October 1 in the Philadelphia Court of Common Pleas.
The plaintiff, Calvin Johnson, blames the drug on damage to his urinary tract, which caused kidney stones and blood in his urine. He is seeking $50,000 in damages for injuries that were allegedly caused by atorvastatin, a generic form of Lipitor that was manufactured in India by Ranbaxy Pharmaceuticals.
In November 2012, the FDA ordered a recall for certain lots of generic Lipitor that may be contaminated with very small glass particles similar to the size of a grain of sand (less than 1-mm in size).
The FDA determined that the risk of heath problems was “extremely low,” and “if any adverse events are experienced, they would be temporary.” No injuries were linked to the problem at that time.
Ranbaxy halted production to fix issues and resumed sales in February 2013. One year later, the FDA prohibited several Ranbaxy facilities in India from shipping drugs into the United States due to ongoing quality-control issues.
This is not the first time Ranbaxy has recalled generic Lipitor. In May 2014, the Indian drug-maker recalled more than 64,000 bottles of the drug after a pharmacist discovered a 20-mg tablet in a sealed bottle marked for 10-mg pills.
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