Lipitor Recall Issued for 191K Bottles Due to Musty Odor

A recall for Lipitor has been issued by Pfizer, Inc. for 191,000 bottles of the cholesterol drug due to reports of a musty odor, which may have been caused by some bottles being stored on pesticide-treated pallets. 

The Lipitor recall was announced this week in an FDA enforcement report, affecting seven lots of the drug sold in the United States and Canada, as well as three lots that were sold to a Canadian generic drug supplier. All were packaged in bottles from a third-party supplier.

The recall came after the drug maker began to receive reports from consumers about an odor from the Lipitor bottles. At least one illness has been reported in connection to the odor, but Pfizer claims that the illness was unrelated.

According to the FDA, 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 that the bottles were actually recalled in August, but the announcement was not made until this week, to coincide with the FDA enforcement report.

Lipitor (Atorvastatin) was approved by the 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 more than $11 billion last year and is the best-selling prescription drug in the U.S.

The recall affects 191,000 90-count bottles of 40 mg Lipitor and three lots of a generic. Five of the lots were sold in the U.S. and the rest were distributed in Canada. The five U.S. lot numbers, according to FDA, are 0855020, 0819020, 0842020, 0843020, and 0854020. All of the recalled lots have an expiration date of January 2013.

Pfizer has said that the recall will not cause a Lipitor shortage.

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. 

The side effects of Lipitor and other statins have come under increasing scrutiny recently. In February, a study published in the medical journal, The Lancet, found that people using cholesterol drugs faced a 9% increased risk of being diagnosed with type 2 diabetes.  Other studies have found that about 1 in 10,000 statin users develop a sometimes-fatal muscle condition known as rhabdomyolysis. The rare condition causes skeletal muscle damage and releases myoglobin into the bloodstream. The myoglobin can cause severe kidney failure or death.

In 2002 and 2008, the FDA issued warnings about the increased risk of rhabdomylosis when statins are used in combination with heart medication containing amiodarone. In 2001, the statin-based drug Baycol was removed from the market due to its links with rhabdomyolysis.