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Ranbaxy recalls generic Lipitor in US

Several batches withdrawn after some products found to contain small particles of glass


Ranbaxy Pharmaceuticals has recalled several batches of its generic Lipitor in the US after some products were found to contain small particles of glass.

The generics firm, which is owned by Daiichi Sankyo, said it was making the voluntary recall of the cholesterol-lowering medicine as an “abundance of caution” and it would only affect select lot numbers in the US.

The Food and Drug Administration (FDA) has been informed of the withdrawal, said Ranbaxy, although the recall will be conducted by Ranbaxy itself.

According to Reuters, Ranbaxy is conducting an investigation into the contamination, which it expects to take two weeks. No injuries have been reported so far regarding the affected batches.

Lipitor, which goes by the generic name atorvastatin, is one of the biggest selling drugs in the world, and made billions for Pfizer during its period of patent protection.

Ranbaxy became the first company to launch a generic version of the drug in late 2011, gaining a 180 day period of exclusivity in the process. During this time, the only other company able to sell atorvastatin was Watson, which markets Pfizer's authorised generic product.

This exclusivity helped establish Ranbaxy as one of the market leaders in generic atorvastatin, meaning the product recall could cause shortages, an FDA spokesperson told PMLiVE.

They said: [T]he FDA is currently working with the other manufacturers to address any potential shortage as a result of the ongoing recall."

Regarding patient safety, they said: "Product from the affected lots of atorvastatin may have been dispensed to patients and may have already been consumed. Patients concerned about the product they have on hand should contact their pharmacist and consult with their physician."

Versions of the drug affected by the recall are 10mg, 20mg and 40mg dosage strengths, packaged in 90 and 500 count bottles.

The recall does not affect the 80mg strength of Ranbaxy's atorvastatin, nor any products outside the US.

Ranbaxy has posted a full list of affected batches on its website.

27th November 2012

From: Sales, Regulatory



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