Musty odors are at it again, this time driving a Pfizer recall of the cholesterol-fighting blockbuster Lipitor. The drug giant recalled 191,000 of the 40-mg, 90-count bottles in August, following three complaints.
This may be a case of bad luck coming in threes: the three-complaint Pfizer recall marks the third musty-odor recall this year from what appears to be three Puerto Rican manufacturing sites.
The three complaints yield a malodorous-bottle frequency of less than one in a million, the company says. Three additional lots supplied by Pfizer to a generics-maker also were recalled. All of the recalled bottles originate from the same batch.
Pfizer says it is working with the bottle maker to determine the cause, which is unlikely harmful. But the October 6, 2010, FDA enforcement report cites chemical contamination and names 2, 4, 6 tribromoanisole as the culprit. That's the same transgressor fingered in the Depomed recall of diabetes drug Glumetza last June. And the chemical gained notoriety in last December's Johnson & Johnson/McNeil recall of six million bottles of Tylenol arthritis caplets. The contaminant is a byproduct of a fumigant used on wooden shipping pallets.
Pfizer is not yet convinced, according to Consumer Ally. The TBA contaminant was detected at low levels but hasn't been confirmed as the source of the odor.
The recalled Lipitor, distributed in the U.S. and Canada, was made by a contractor that Pfizer didn't identify. But the FDA names packager Rexam, of Las Piedras, Puerto Rico, as one of the recalling manufacturers. Both the recalled Tylenol and Glumetza products also were manufactured in Puerto Rico.