Another Lipitor Recall Issued Over Musty Odor

Pfizer has announced yet another Lipitor recall due to problems with musty odors that are likely caused by pesticide contamination. 

The latest Lipitor recall (pdf) affects about 19,000 bottles that were distributed in the U.S. The recall was issued by Pfizer after a customer reported an uncharacteristic odor from the bottles, which were supplied by a third-party manufacturer. 

The odor is likely caused by 2, 4, 6 tribomoanisole (TBA), a byproduct of a pesticide used on wood pallets, Pfizer said in its press release. TBA has been linked to a number of drug recalls due to its distinctive odor, which has reportedly caused mild gastrointestinal illnesses in some consumers.

Earlier this year, TBA contamination resulted in a recall of millions of bottles of Tylenol, Motrin and other Johnson & Johnson over-the-counter drugs. 

Pfizer said it prohibits the use of 2, 4, 6-tribromonophenol (TBP), the pesticide that causes TBA, in the wood used to ship its medicines. The company says the lot affected by the latest recall was shipped before the policy went into effect in August. 

This is the fourth Lipitor recall this year due to TBA contamination. Previous recalls of Lipitor were issued in August, early October and late October of this year. The largest occurred in early October, when the company recalled about 191,000 bottles. Altogether, about 390,000 bottles of Lipitor have been pulled from shelves due to the odor. 

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.