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 is the result of 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, Pfizer says.
Funny smell
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.
Pfizer says it has "a very rigorous quality and compliance program that includes a
highly sensitive surveillance system," which the company says has enabled
it to detect and respond to the odor-related issue quickly.
The drug maker says it does not anticipate a product
shortage resulting from the recall.
Lipitor is a prescription medicine that is used along with a
low-fat diet. It lowers the LDL ("bad") cholesterol and triglycerides
in your blood. It can raise your HDL ("good") cholesterol as well.
The medication can lower the risk for heart attack, stroke,
certain types of heart surgery, and chest pain in patients who have heart
disease or risk factors for heart disease such as age, smoking, high blood
pressure, low HDL, or family history of early heart disease.
It can also lower the risk for heart attack or stroke in patients with diabetes and risk factors such as diabetic eye or kidney problems, smoking, or high blood pressure.
