Pfizer is expanding its recall of 40 mg LIPITOR tablets due to an odor emanating from the bottles in which they were packaged.
The announcement adds two lots — approximately 38,000 bottles — to the previous recall, after two customers reported uncharacteristic odors related to the bottles. No illnesses have been reported.
The most recent recall involving LIPITOR was October 13, 2010 when the company announced that 10 lots of the tablets, or nearly 192,000 bottles were potentially affected by the odor. Pfizer’s first recall of LIPITOR happened in August when it announced that seven lots, or 140,000 bottles, were affected.
The pharmaceutical company believes the problem originated at a third-party bottle manufacturing facility in Puerto Rico. The odor is caused by a contamination of trace amounts of a chemical compound called 2,4,6-tribromoanisole, or commonly referred to as TBA. The source of TBA is believed to be another similar-sounding chemical, TBP, which has been used on wood pallets to distribute products for Pfizer and other manufacturers, such as McNeil Consumer Healthcare, a division of Johnson & Johnson. McNeil announced a major recall in January 2010 affecting Tylenol and other products after consumers complained of an unusual musty odor, and that recall was later expanded as well.
Pfizer ordered changes in the factory in August 2010. The lots affected by LIPITOR’s three recalls this year were packaged and shipped prior to August. Among the changes the factory instituted was enhancing its ventilation system, in order to minimize conditions allowing TBA to form.
