Lipitor recalled for third time this year

After consumers complained about an odor on Lipitor bottles, Pfizer said it will recall 38,000 bottles of the cholesterol drug. (Mel Evans/Associated Press)

By Matthew Perrone

Associated Press / October 30, 2010

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WASHINGTON — US drug maker Pfizer Inc. announced yesterday it would recall 38,000 bottles of its blockbuster cholesterol drug Lipitor because of an unpleasant odor, the third recall this year related to the problem.

The drug maker said the latest recall was triggered by two consumer complaints about a musty or moldy odor on Lipitor bottles, which are made by a company in Puerto Rico.

Pfizer has recalled more than 360,000 bottles of Lipitor in the last three months because of the issue. The company recalled 140,000 bottles in August and another 191,000 earlier this month.

Yesterday’s action affects two product lots.

Similar complaints have triggered multiple recalls by competitor Johnson & Johnson in the past year. While patients have reported nausea and diarrhea after using those products, the risk of serious harm is remote, according to a memo from the Food and Drug Administration.

As with the J&J recalls, Pfizer said the issue was caused by trace amounts of a chemical called 2,4,6-tribromoanisole, which is used to treat wooden pallets often used to store and ship bottles.

Pfizer said its inspectors found the chemical in packaging materials and wooden pallets at the Puerto Rican plant that supplies its bottles.

“We have identified the source of the odor and we are enacting rigorous measures to prevent odor-related issues going forward,’’ the company said in a statement.

The company warned that there could be additional recalls of products previously shipped from the plant. However, no bottles have tested for the odor since changes were made in August, according to Pfizer.