Unusual Odor Leads to Lipitor Recall

FDA Links Problem to Same Contaminant Found in McNeil Recall

October 13, 2010 05:20 pm News Staff

Pfizer Inc. is recalling more than 190,000 bottles(www.fda.gov) of its cholesterol-lowering drug atorvastatin, which is marketed as Lipitor, following reports of an uncharacteristic odor related to the bottles in which the medication is packaged.

[Image of Lipitor package label]

The FDA said in an Oct. 6 enforcement report(www.fda.gov) that the source of the odor has been identified as 2,4,6-tribromoanisole, which is a degradant of 2,4,6-tribromophenol, a pesticide and flame retardant used to treat wooden pallets.

The same contaminant and odor problem was responsible for a massive recall of OTC products by McNeil Consumer Healthcare earlier this year.

The Pfizer recall of 191,000 bottles affects 40 mg Lipitor tablets packed in 90-count bottles. The following lots are affected:

  • 0855020,
  • 0819020,
  • 0842020,
  • 0843020 and
  • 0854020.

All of the lots carry a January 2013 expiration date.

Pfizer said in its recall notice that the odor "is not likely to cause adverse health consequences." According to Pfizer spokesman Mackay Jimeson, patients who experience an uncharacteristic odor associated with their medication should contact their pharmacy for a product replacement. The company is not offering consumers refunds for recalled product.

Pfizer said it is working with its bottle supplier to address the odor problem. The manufacturer also said that it does not expect any shortages of its product to result from the recall.

Patients with questions about the recall may call Pfizer's information center for Lipitor toll-free at (888) LIPITOR [547-4867].