Lipitor recall

Atorvastatin recall due to “uncharacteristic odor”
October 9, 2010 | Sue Hughes
New York, NY – Pfizer has recalled seven lots of atorvastatin (Lipitor) because of an “uncharacteristic odor related to the bottles in which the product is packaged. [1]” The recall actually occurred in August, but the company only issued a statement about it this week when it appeared in the US FDA enforcement report issued on October 6, 2010 [2].

The recall related to 191 000 bottles each containing 90-count 40-mg atorvastatin tablets. The reason given was “chemical contamination” with “complaints of an uncharacteristic odor identified as 2,4,6-tribromoanisole.” The company added that a medical risk assessment has determined that the odor issue is not likely to cause adverse health consequences for patients. It said there were three reports of odor problems during the month of July, which translates into a frequency rate of less than one report per one million bottles of product packaged, and said that the company will be actively monitoring the situation going forward to ensure patient safety.

The lot numbers affected were 0855020, 0819020, 0842020, 0843020, 0854020, all with expiration dates of 01/13. Pfizer said that the recall included three additional lots of atorvastatin supplied to a Canadian company and that all the lots were packaged in the same batch of bottles from a third-party supplier.

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