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./;.../
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