The world's top drug maker recalled 191,000 bottles of its anti-cholesterol drug Lipitor due to reports of a moldy odor emanating from bottles supplied by a third-party – the same problem that resulted in the recall of millions of Tylenol bottles.
Pfizer spokesman Rick Chambers said the company recalled seven lots of Lipitor (five in the U.S. and 2 in Canada) in August "due to a small number of reports of uncharacteristic odor related to the bottles in which the product is packaged."
Three additional lots of the drug Pfizer supplied to a Canadian generic drug manufacturer were also recalled, he added. All the recalled bottles were packaged in the same batch from an unnamed third-party vendor. Chambers said Pfizer does not know how many of the tainted bottles have been shipped or sold.
Although there has been one reported illness, Chambers says the company does not believe it is related to a malodorous Lipitor bottle. "We received one adverse event report involving the recalled product, but it is unlikely to have been related to the odor issue," Chambers said. "A medical risk assessment based on all the information we have has determined that the odor issue is not likely to cause adverse health consequences for patients."
The recall notice posted on the U.S. Food and Drug Administration website said the recall was issued due to "Chemical Contamination: complaints of an uncharacteristic odor identified as 2, 4, 6 tribromoanisole." According to the brief notice, the recalled lots of 40mg, 90-count bottles, which expire in January 2013, are as follows: 0855020, 0819020, 0842020, 0843020, 0854020.
Tribromoanisole, commonly known as TBA, results from the breakdown of Tribromophenol, a fungicide used to treat wooden pallets that transport and store packaged materials, such as drugs.
TBA, which produces a musty, mildew-like odor was also responsible for the multiple recalls of Johnson & Johnson's Tylenol and other brand-name drugs in December 2009, and January, June, and July of this year. The initial Tylenol recalls were prompted by reports of consumers suffering from nausea, stomach pain, vomiting and diarrhea.
"TBA was detected at very low levels in a sample from one lot in the recall, but we do not know if TBA is the source of the odor," Chambers told Consumer Ally.
Pfizer first received reports of the odor in July. Chambers said Pfizer is working with the bottle supplier to determine and address the cause of the odor, and doesn't anticipate a Lipitor shortage.
The drug was also recalled in 2003 and 2005 due to fears of counterfeit Lipitor.
Pfizer recalled 191,000 bottles of Lipitor due to odor