From Our 2010 Archives
Lipitor Recall Grows by 19,000 Bottles
Smelly Bottles Plague Popular Cholesterol Drug
By Daniel J. DeNoon
Reviewed by Laura J. Martin, MD
Latest Medications News
Dec. 21, 2010 -- The Lipitor recall continues with Pfizer's recall of 19,000 more bottles of the popular cholesterol drug.
A musty smell has led to four recalls, totaling 345,000 bottles since August 2010.
The latest recall is dated Dec. 17 on Pfizer's web site. The 19,000 bottles represent a single lot of Lipitor. Pfizer says one customer complaint spurred recall of the entire lot.
The bottle's musty odor comes from TBA, a chemical used to treat the wooden pallets on which the product was stored. Pfizer says the smelly bottles were supplied by a third-party bottle manufacturer, and that the company prohibits use of TBA-treated wood to ship its medicines.
According to the FDA, people can detect the odor of TBA even when the chemical is present in extremely tiny amounts. Although nobody really knows whether TBA can be toxic -- studies are few and inconclusive -- the FDA concludes that "health risks appear to be minimal."
However, some people have reported "gastrointestinal events" because of the foul odor or taste of the drug stored in bottles contaminated with trace amounts of TBA.
Pfizer is not the only drug company affected by musty packaging. TBA in storage pallets is blamed for recent recalls of Johnson & Johnson's Tylenol.
All of the recalled bottles contain Lipitor 40 milligram tablets. The lot number of the current recall is 0836050.
SOURCES: News release, Pfizer.Lipitor.com.FDA web site.Richard T. Chambers, corporate affairs, Pfizer.