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

The company initiated a voluntary recall of 2,280 bottles of Atorvastatin Calcium 40 mg 500 tablets on August 2

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Last Updated : Aug 24 2018 | 12:02 AM IST

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.