Pfizer Expands Lipitor Recall in US
Due to reports of a musty or moldy odor, Pfizer Inc has expanded its recall to include another 38,000 bottles of Lipitor (atorvastatin calcium) 40-milligram tablets that were distributed in the United States. The latest recall follows two prior recalls of the best-selling prescription drug – one in August and one earlier this month.
Pfizer said today that the odor is consistent with the presence of a chemical called 2,4,6 tribromoanisole, or TBA, which is used as a wood preservative on the pallets used to transport and store products. TBA was found at a very low level in a sample returned by a consumer during the probe that led to the first recall.
The FDA reports that a medical assessment has determined that the odor is not likely to cause adverse health consequences.
Pfizer spokesperson Ray Kerins said that after the initial recall, the company took steps to reduce the risk of TBA contamination, but that the lots involved in the latest recall were packaged and shipped before those changes were made. Pfizer has identified the source of the problem in the company’s Puero Rico plant.
Pfizer states that the recall only applies to “specific lots” of 40 milligram tablets of Lipitor and that patients should only return the medication to their pharmacist if they notice an uncharacteristic odor. Pfizer is not offering a refund, but for more information about the lot numbers involved, consumers can call the company at 1-888-LIPITOR.