Anti-cholesterol Drug Lipitor® Recalled
October 21, 2010
Drug manufacturer Pfizer announced that it recalled almost 200,000 bottles of its blockbuster anti-cholesterol drug Lipitor® (atorvastatin) due to reports of a musty odor coming from some bottles.
The recall, which took place in August 2010, involved seven lots of 40 mg Lipitor manufactured by a third-party supplier. Five of the recalled lots were distributed in the United States; two additional lots were distributed in Canada, according to news reports. "A medical assessment has determined that the odor is not likely to cause adverse health consequences in patients taking Lipitor," according to a statement by Pfizer posted on Lipitor.com.
According to the U.S. Food and Drug Administration's website, the source of the musty odor is a chemical known as 2, 4, 6 tribromoanisole, a frequent cause of musty odors in packaged goods. Tribromoanisole is often found on wood shipping pallets that have been chemically treated with a fungicide.
The Lipitor recall echoed similar recalls of Tylenol® and Motrin® (manufactured by Johnson & Johnson) this year due to reports of an odd smell coming from bottles of those products. Tribromoanisole was also implicated in that recall.
The FDA reports the following five U.S. lots of Lipitor have been recalled. All have an expiration date of January 2013:
If you notice an uncharacteristic odor associated with your Lipitor medication, Pfizer recommends that you return it to your pharmacist. If you have additional questions about Lipitor, consult your doctor, a pharmacist or call Pfizer at 1.888.LIPITOR.
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Sources: Pfizer; FDA; and News reports.