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Ranbaxy Begins Atorvastatin Recall

Generic Lipitor lots pulled due to possible glass particle contamination

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Ranbaxy, Inc., a subsidiary of India’s Ranbaxy Laboratories Ltd., has initiated a voluntary recall of 41 affected lots of Atorvastatin Calcium Tablets (10 mg, 20 mg and 40 mg), a generic of Pfizer’s Lipitor. The voluntary action is being taken as a precautionary measure due to the possibility that the affected lots may contain very small glass particles resembling a fine grain of sand.
 
On November 23rd, Ranbaxy posted a notice of the recall on its U.S. website, covering 10 mg, 20 mg and 40 mg doses of tablets of atorvastatin calcium, but not the 80 mg dosage. “Ranbaxy is proactively recalling the drug product lots out of an abundance of caution,” the website statement read. “This recall is being conducted with the full knowledge of the U.S. FDA.”
 
According to the company, the probability of an adverse event due to consumption of this product is unlikely but cannot be ruled out. To date, the company has not received any reports of adverse events related to this recall.

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