For the third time in as many months, Pfizer has issued a recall of its blockbuster cholesterol drug Lipitor in response to consumer complaints of unusual moldy odor.
The drug giant said the smell poses minimal health risk to patients, but it is recalling two lots -- approximately 38,000 bottles of Lipitor 40mg tablets -- out of caution. An internal company investigation, triggered by two customer complaints, found the odor was related to Tribromoanisole, a chemical used as a wood preservative. Pfizer suggested a third-party bottle manufacturer had applied it to packaging for the shipment of its medicines.
Earlier this month, the world's top drug maker recalled 191,000 bottles of the cholesterol-lowering drug over the same issue. And in August, it withdrew 140,000 bottles from the market.
In a statement, the company said the recall is a result of increased surveillance of odor-related issues after other reports in the industry. Johnson & Johnson's multiple recalls since last year of over-the-counter medicines included the withdrawal of malodorous Tylenol that had sickened consumers.
Tribromoanisole is often applied to pallets used to transport and store products. Pfizer says as a result of stepped-up monitoring, it now prohibits its use in the shipment of its drugs. The recalled Lipitor lots were packaged and shipped before these changes went into effect, the company said.
Lipitor is the best-selling drug in the world, with nearly $6 billion in sales in the first half of 2010.
Pfizer recalls Lipitor for a third time since August due to moldy smell