October 7, 2014 — A man who says he was injured by glass particles in generic Lipitor (atorvastatin) has filed a lawsuit against its manufacturer, Ranbaxy Pharmaceuticals.
Courthouse News reports that the plaintiff, Calvin Johnson, is seeking $50,000 in damages for urinary tract injuries, including a kidney stone and blood in his urine. The lawsuit was filed in the Philadelphia Court of Common Pleas on October 1.
Johnson blames his injuries on tiny particles of glass in atorvastatin, a generic form of Lipitor that was manufactured in India by Ranbaxy Pharmaceuticals.
In November 2012, certain lots of generic Lipitor were recalled because the FDA was concerned they might be contaminated with glass particles roughly the size of a grain of sand (less than 1-mm).
The FDA classified the recall as “Class II” and said they believed the risk of injury was “extremely low.” No reports of injury were linked to the recall, and the FDA said if any injuries did occur, they would be temporary.
Soon after the recall, Ranbaxy halted production to fix the problems. Production resumed in February 2013. However, the following year, the FDA shut down several Ranbaxy facilities in India due to serious lapses in quality-control.
Unfortunately, problems persist. In May 2014, Ranbaxy recalled 64,000 bottles of atorvastatin due to a possible dosage mix-up. The recall was issued after a pharmacist reported finding a 20-mg tablet in a sealed 10-mg bottle of atorvastatin.