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When you open a medicine bottle, it’s reasonable to expect that the pills inside are safe, effective and generally made to specification.

But that isn’t always true. Case in point: an ongoing recall of a cholesterol drug called atorvastatin.

Atorvastatin – a statin better known by its brand name, Lipitor – is the top-selling medication in the U.S., with over 115 million prescriptions going to more than 29 million Americans.

The current recall of generic atorvastatin, announced last month, affects 142,000 bottles manufactured in India and distributed by a company in New Jersey. Those bottles contain enough tablets to fill a monthly prescription for potentially hundreds of thousands of patients.

Clinical pharmacist C. Michael White, from the University of Connecticut, lays out what exactly is being recalled and why. He also offers a wider perspective on drug safety. As many aspects of drug manufacturing have moved overseas, he writes, the FDA has struggled to stay abreast of quality testing that’s required for drugs sold in the U.S., leaving consumers “largely at the mercy of spotty inspections and testing.”

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Alla Katsnelson

Associate Health Editor

Several batches of the drug did not dissolve properly, which means the person taking them would receive a lower dose. Chimperil59/iStock via Getty Images

Atorvastatin recall may affect hundreds of thousands of patients – and reflects FDA’s troubles inspecting medicines manufactured overseas

C. Michael White, University of Connecticut

This recall affects America’s most prescribed drug. It’s the latest in a series of concerning manufacturing issues that have come to light over the past few years.

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