Pfizer Inc said it recalled 191,000 bottles of its top-selling Lipitor cholesterol fighter following reports of a musty odor coming from some bottles of the medicine made by a third-party supplier.
The world's largest drugmaker said the recall, which took place in mid-August, involved seven lots of 40 milligram Lipitor, as well as three other lots of the medicine supplied to a Canadian generic drugmaker. Five of the seven recalled lots of the branded medicine were in the United States, while two were recalled from Canada, Pfizer said.
The recall was initiated after the company received three reports from consumers complaining about the musty odor, including one so-called adverse event report, Pfizer spokesman Rick Chambers said.
The health problem reported by the consumer was found to be not likely to be related to the odor problem, Chambers said.
Even with declining revenue amid generic competition in some countries, such as Canada, Lipitor remains the world's largest-selling prescription medicine with annual sales in excess of $11 billion.
The U.S. Food and Drug Administration is aware of the recall and monitoring the situation, Pfizer said.
The company declined to identify the supplier or plant where the problem originated, but said there were no supply shortages of 40 mg Lipitor that would affect patients.
"We're working closely with the supplier to guarantee that we can meet our supply demand, including changing the way that the bottles are packaged at the bottle supplier, decreasing time to delivery, and relocating some bottle production to other facilities operated by the supplier," Chambers said.
The recall was too small to require Pfizer to take a charge to account for it, Chambers said.
But sensitivity to such issues is especially high after Johnson & Johnson's massive recall of Tylenol, Motrin and other consumer healthcare products, including one that was initiated by reports of foul odors coming from bottles of the products.