Dr Reddy's recalls cholesterol lowering Atorvastatin tablets in the US

Dr Reddy's Laboratories Limited has recalled cholesterol lowering Atorvastatin Calcium tablets from the US market after noticing certain anomalies in the out of specifications(OOS) investigations. 

The company initiated a voluntary recall of 2,280 bottles of Atorvastatin Calcium 40 mg 500 tablets on August 2, according to the US Food and Drug Administration(USFDA). This is a class-3 recall, which means the noticed deviations, if exposed to, are unlikely to cause adverse health consequences.   

"Failed impurities/degradation specifications-OOS was observed for ATV cyclo FP impurity and total degradation impurities tested at the 18 month stability time point in Atorvastatin Calcium tablets 40 mg 500 tablets," a notice on the US FDA website said.   


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