NEW YORK (MainStreet) – Pfizer is recalling another 19,000 bottles of Lipitor, a prescription drug that treats high cholesterol and heart disease after consumers reported smelling an “uncharacteristic odor” upon opening them.
The recall, announced Tuesday, marks the fourth time this year that the drug manufacturer has pulled its popular medication for odor issues. To date, the company has recalled more than 360,000 bottles of Lipitor.
According to Pfizer, the odor is being caused by the presence of 2, 4, 6 tribromoanisole (TBA), a chemical that often is applied to pallets used to transport and store a variety of products. While Pfizer said it prohibits use of the chemical in shipment of its medicines, the contaminated bottles were supplied by a third-party bottle manufacturer, which is no longer being used by the company.
“The lot [being] recalled was packaged and shipped before these changes went into effect in August of this year,” the company said in a written statement. “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.”
The newly-recalled bottles of the 40 mg version of the drug have the lot number o0836050. Check here for a full list of lot numbers affected in all of Pfizer’s Lipitor recalls.
The company also said a medical assessment found that the risk of health consequences to patients is minimal, an assertion supported by the Food and Drug Administration (FDA), which found that no serious adverse health effects have resulted from ingestion of drugs or foods contaminated with TBA.
However, both FDA and Pfizer recommend that those with affected bottles bring them to a pharmacist for a replacement. Despite the recalls, Pfizer is not anticipating a shortage of the drug.
Patients can direct additional questions about the recall their doctor or pharmacist. They can also call 1-888-LIPITOR for more information.