This is a reprint of the FDA alert.
December 22, 2010 – Pfizer has announced that it intends to recall one lot—approximately 19,000 bottles—of Lipitor 40 mg tablets (atorvastatin calcium) distributed in the U.S. The recall stems from one customer 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.
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 of 2010, 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-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.
For the U.S. FDA’s perspective on TBA and health risk, click on the following web site: FDA Guidance, Compliance and Regulatory Information.
The company has taken quick action to ensure its product continues to meet the company’s high quality and patient safety standards. We have identified the source of the odor, and we are enacting rigorous measures to prevent odor-related issues going forward. 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 has a very rigorous quality and compliance program that includes a highly sensitive surveillance system, which has enabled Pfizer to quickly detect and respond to the odor-related issue. Our market actions reflect the rigor of our quality control system and a commitment to act rapidly and in the best interest of our customers. The well being of patients who take our medicines is our first priority.
Pfizer does not anticipate a product shortage resulting from the recall.
Pfizer recalled specific bottles of LIPITOR (40 mg only) due to a small number of reports of an uncharacteristic odor related to the bottles in which LIPITOR is packaged. A medical assessment has determined that the odor is not likely to cause adverse health consequences in patients taking LIPITOR. There is no need to take any action if you take LIPITOR; please continue to take your medication as prescribed by your doctor. However, if you take LIPITOR 40 mg and experience an uncharacteristic odor associated with your medication, please return the tablets to your pharmacist.
Pfizer is committed to the safety of patients who take our medicines. Pfizer is working closely with the bottle supplier to determine the cause of the odor problem and to rapidly address it. Pfizer responded rapidly to ensure LIPITOR continues to meet the company’s high quality standards. We will continue to actively monitor the situation and take any action necessary to ensure patient safety and maintain the quality of our products.
If you have any questions about LIPITOR, please contact your doctor or your pharmacist or call 1-888-LIPITOR.