Drug developer Pfizer Inc. on Tuesday recalled a batch of 19,000 bottles of the blockbuster cholesterol drug Lipitor, citing a consumer complaint about an "uncharacteristic" odor.
The latest announcement marks the fourth such recall since August over similar issues. Pfizer said the bottles were supplied by an outside manufacturer, though it did not identify the party. It also says health consequences appear to be minimal.
The recall covers the lot of bottles containing 40-milligram tablets and the company said the odor is consistent with prior recalls, which have been traced to 2,4,6-tribromoanisole, a chemical used as a wood preservative. The chemical is often applied to pallets that are used to transport and store products, but Pfizer said it prohibits its use in the shipment of its medicines.
The New York company made changes in August in a move to fix the problem and said the lot currently being recalled was shipped before the changes. Additional recalls may be necessary for other batches of Lipitor in bottles made by the supplier that were shipped before August.
"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," the company said in a statement. "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 company has now recalled more than 360,000 bottles of Lipitor because of the odor issue, but said the latest recall will not result in a shortage. Lipitor is the best-selling prescription drug in the U.S., with about $7.5 billion in sales last year.
Similar odor complaints have triggered recalls by competitor Johnson & Johnson in the last year. Patients reported nausea and diarrhea after using those products, but the risk of serious harm is remote, according to a memo from the Food and Drug Administration.
- Pfizer Inc.
- Food and Drug Administration
- wood preservative
- quality control system