From Our 2010 Archives

Lipitor Recall: Unusual Odor, No Health Problems Reported

No Health Risk Likely, Says Maker of the Cholesterol-Lowering Drug

By Miranda Hitti
WebMD Health News

Reviewed by Laura J. Martin, MD

Oct. 8, 2010 -- The drug company Pfizer is recalling 191,000 bottles of Lipitor, the cholesterol-lowering statin drug, due to complaints of an unusual odor.

In a statement emailed to WebMD, Pfizer spokesman Rick Chambers writes that there have been "a small number" of reports of the "uncharacteristic odor related to the bottles in which the product is packaged." Pfizer and the bottle supplier are investigating the source of the smell.

Health problems related to the smell aren't likely, according to Chambers.

"A medical risk assessment based on all the information we have has determined that the odor issue is not likely to cause adverse health consequences for patients," Chambers states.

The recall includes the following five lots of Lipitor bottles in the U.S.:

  • 0855020
  • 0819020
  • 0842020
  • 0843020
  • 0854020

Each bottle contains 90 Lipitor tablets in a 40-milligram dose. All of those lots have an expiration date of 01/13, according to the FDA.

Two other lots of Lipitor bottles are being recalled in Canada.

Pfizer got three reports of the smell in July and the recall began in August. The recall notice was posted on the FDA's web site yesterday.

The recall isn't expected to trigger any Lipitor shortages, Chambers says.

SOURCES: FDA.Statement, Richard T. Chambers, spokesman, Pfizer.

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