Recall of Lipitor Issued for 38K More Bottles Over Bad Smell

About 38,000 more bottles of Lipitor will be recalled due to possible contamination with a pesticide that causes the bottles of the cholesterol drug to have a bad smell or musty odor. 

An additional two lots of the medication were added to a prior recall of Lipitor, which was first announced in August and previously expanded last month for the same reasons. This brings the total number of Lipitor bottles affected by the recall to about 369,000.

Pfizer, Inc. announced its intent to expand the recall in a press release (pdf) on October 30, after receiving two customer reports of musty odors from the two additional lots. However, the company has not yet released the lot numbers for the most recently recalled bottles of 40 mg tablets.

The odor has been identified as 2, 4, 6 tribromoanisole, or TBA; a pesticide used to treat wood pallets where medicines are often stored. The same substance led to a massive recall of Johnson & Johnson drugs late last year, including Tylenol, Motrin, and Benadryl. In that case, the substance was reported to make people ill. Pfizer says the physical effects of the contaminated Lipitor are minimal.

Lipitor (Atorvastatin) was approved by FDA in December 1996 for use in lowering cholesterol. It is a member of a class of drugs called statins and works by inhibiting an enzyme in the liver that takes part in cholesterol production. Lipitor brought in $12.4 billion in sales for Pfizer in 2008.

The recall comes shortly after the U.S. Department of Justice (DOJ) filed a brief in support of a Lipitor whistleblower lawsuit by a former company executive who says that Pfizer misled doctors about the health benefits of the drug. Pfizer has called for the lawsuit to be dismissed, but the DOJ brief attacked the call for dismissal on a number of grounds. The DOJ declined to join the lawsuit, however.