Pfizer has recalled one lot of approximately 19,000 bottles of Lipitor 40 mg tablets (atorvastatin calcium) distributed in the U.S. The recall stems from a customer report of an “uncharacteristic odor” related to the bottles in which these lots of Lipitor were packaged, the company said.
The bottles were supplied by a third-party bottle manufacturer, according to the New York City-based Pfizer, which added that a medical assessment found that the health consequences risk to patients appears to be minimal.
The recall corresponds to Pfizer's increased surveillance of odor-related issues after other reports in the industry. This increased surveillance also led to three earlier recalls of Lipitor, implemented in August, October and November of 2010, in response to complaints of an uncharacteristic odor.
According to the pharmaceutical company, the odor is consistent with the presence of 2, 4, 6 tribromoanisole (TBA), which was found at a “low level in a complaint sample bottle during the investigation, leading to the first product recall.” Research indicates that a major source of TBA appears to be 2, 4, 6-tribromonophenol (TBP), a chemical used as a wood preservative.
“Although TBP often is applied to pallets used to transport and store a variety of products, Pfizer prohibits the utilization of TBP-treated wood in the shipment of its medicines,” the company said.
Pfizer said it does not anticipate a product shortage resulting from the recall.