Recall: Atorvastatin (Lipitor) that give off a musty odor have been found

Lipitor Odor Problem Continues, Recall Expands

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By John Gever, Senior Editor, MedPage TodayPublished: December 21, 2010

More bottles of atorvastatin (Lipitor) that give off a musty odor have been found -- prompting its manufacturer, Pfizer, to expand its ongoing recall.
The new recall involves an additional, unspecified lot of 19,000 bottles of atorvastatin 40 mg, bringing the total pulled off the market to 360,000 bottles.
In a statement, Pfizer attributed the musty odor to a compound called 2,4,6-tribromoanisole (TBA), identified in a bottle of atorvastatin that prompted one of the original consumer complaints.

The FDA has indicated that the health effects of TBA at low concentrations are "minimal," mainly gastrointestinal distress in consumers who have swallowed products affected by the odorous compound.

TBA may actually originate with another chemical known as TBP, used as a wood preservative in shipping pallets and other products, according to Pfizer. However, the company said it prohibits the use of TBP-treated pallets by its shippers, and U.S. pallet manufacturers are also forbidden to use TBP.

However, the FDA said TBP may be present in wood products supplied to the U.S. from other countries.

Pfizer began the recall in August, but did not make a public announcement until October when it broadened the recall to additional lots of atorvastatin. The company said the firm that supplied the bottles changed its methods in August to fix the problem, but the lot involved in the newest recall was produced before then.

"Product filled in bottles made by the supplier prior to those changes may still be on the market, so it is possible that additional recalls could be necessary," Pfizer said.
Reports of musty odors also prompted Johnson & Johnson's massive recall of Tylenol brand acetaminophen products that began in 2009, which was followed by additional recalls of other drugs that had prompted similar complaints.

The Tylenol odor problem, now the subject of an FDA criminal investigation, eventually led to a management shakeup at Johnson & Johnson.

Pfizer's CEO unexpectedly announced earlier this month that he was stepping down, but the atorvastatin recalls have not been suggested as a reason.