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,"