NEW YORK — Pfizer on Monday announced that it intends to recall one lot — approximately 19,000 bottles — of Lipitor 40-mg tablets (atorvastatin calcium) distributed in the United States because of one customer’s report of an uncharacteristic odor related to the bottles in which these lots of Lipitor were packaged.
The bottles were supplied by a third-party bottle manufacturer. A medical assessment found that the risk of health consequences to patients appears to be minimal, Pfizer reported.
The market action is the result of 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 2010, in response to infrequent complaints of uncharacteristic odor.
“We have identified the source of the odor, and we are enacting rigorous measures to prevent odor-related issues going forward,” Pfizer stated in a press release. “The lot that will be recalled was packaged and shipped before these changes went into effect in August of this year. As previously reported, 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 does not anticipate a product shortage resulting from the recall.