Pfizer recalls drug over odor
Pfizer said Monday it intends to recall one lot — about 19,000 bottles — of Lipitor distributed in the United States.
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The recall stems from a 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.
“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 company said in a statement.
Pfizer said 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.”
The company added that “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.”
