Pfizer has announced that it intends to recall two additional lots—approximately 38,000 bottles—of atorvastatin calcium (Lipitor) 40 mg tablets, distributed in the U.S.
The recall stems from two customer reports of an uncharacteristic odor related to the bottles in which these lots of Lipitor were packaged, the New York City-based company said. The bottles were supplied by a third-party bottle manufacturer.
“A medical assessment found the risk of health consequences to patients appears to be minimal,” Pfizer said.
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 two earlier recalls of Lipitor, implemented in August and October, in response to infrequent complaints of uncharacteristic odor.
The odor is consistent with the presence of 2,4,6-tribromoanisole (TBA), which was found at a very 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-tribromophenol (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 said it prohibits the utilization of TBP-treated wood in the shipment of its medicines.
The FDA released its perspective on TBA and health risk.
The company said it has identified the source of the odor, and is enacting measures to prevent odor-related issues going forward. The lots that will be recalled were packaged and shipped before these changes went into effect in August. Pfizer added that it does not anticipate a product shortage resulting from the recall.