Pfizer Inc. said it plans to recall 38,000 bottles of the cholesterol pill Lipitor, the world’s best-selling drug, because of two more customer reports of a musty-smelling odor in some products.
The odor is consistent with the presence of a chemical called TBA that is linked to a wood preservative used in shipping pallets, the New York-based company said Friday in an e-mailed statement. This is the third Lipitor recall since August because of complaints of an uncharacteristic odor, bringing the total number of bottles to 369,000.
The same chemical was cited in recalls of Johnson & Johnson’s Tylenol and other over-the-counter medicines earlier this year. Johnson & Johnson, based in New Brunswick, N.J., received a warning letter from the Food and Drug Administration in January, saying the drugmaker waited more than a year to notify regulators after getting complaints that tainted bottles of Tylenol may have sickened customers.
Pfizer, the world’s biggest drugmaker, said it reviewed its bottle supplies then and didn’t detect the chemical. The company then increased its monitoring of odor complaints. The bottles involved in the recall were supplied by a third-party manufacturer, and Pfizer prohibits TBA-treated wood in the shipping of its products, according to the statement.
“We don’t anticipate any product shortage,” Ray Kerins, a spokesman for Pfizer, said in a telephone interview Friday. The Lipitor recall won’t have a financial impact, he said. Customers who notice a smell can replace the bottle at their pharmacy without charge, he added.
