Product Recall: Atorvastatin - MedWaste Management Product Recall: Atorvastatin - MedWaste Management

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Product Recall: Atorvastatin

Atorvastatin is a generic form of the popular drug Lipitor. (It’s actually Atorvastatin Calcium, called Atorvastatin for simplicity) Its primary use is limiting the body’s production of cholesterol and other fatty substances.

It went generic  in late 2011 and is one of the five most popular generic drugs since 2012.

Serious though not common side effects may include severe allergic reactions, confusion, muscle pain, depression, painful and/or frequent urination, severe back or stomach pain, and liver problems. More common side effects are joint pain, sore throat, and gastrointestinal issues.

On January 31, 2018, Dr Reddy’s Laboratories initiated voluntary recall of over 80,000 bottles of Atorvastatin Calcium Tablets 10mg, 20mg and 40mg from the US market.

US Food and Drug Administration (USFDA) issued a notification to declare that multiple lots of Atorvastatin 10 mg, 90 count and 500 count bottles; 20 mg, 90 count and 500 count bottles and 40 mg, 90 count bottles, are being withdrawn from the market.

According to the USFDA, the reason for the recall was, “Failed Impurities/Degradations specifications; out-of-specification results observed for Total Degradation Impurities during stability.”

Recall letter from Dr. Reddy’s labs

There have been four major recalls of Atorvastatin Calcium since the popular drug went generic in 2012, with 33 recalls total. The biggest recall was the 2017 Mylan recall of 2.4 million bottles. The reason was “microbial contamination.”

The smallest recall was from Physicians Total Care and it involved only three bottles. There were complaints of an “uncharacteristic odor”, which led to the discovery of foreign chemicals in the tablets.

 Atorvastatin Recall Report

Recalls can cost a lot of money. One way to avoid the high price of drug recalls  is to work with us. We can reduce your Medical Waste Disposal overhead costs.


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