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Pfizer, the world's largest pharmaceutical company, has now issued its fourth recall this year for Lipitor, the number one cholesterol-lowering prescription drug. This time, the company is recalling one lot of approximately 19,000 bottles of 40 mg tablets, again due to a musty odor emanating from the bottles. The odor is likely caused by a fungicide (2,4,6-tribromoanisole) applied to the wooden pallets on which the plastic bottles were stored and shipped. The same problem has plagued Johnson & Johnson's McNeil Consumer Healthcare, resulting in several recalls of Tylenol and other over-the-counter products J&J produces.
Both companies say that the odor is unlikely to cause adverse health affects, although there have been complaints of nausea, vomiting, stomach pains and diarrhea due to exposure to the recalled J&J products. The Food and Drug Administration has issued information about the health risks associated with exposure to the fungicide.
In total, Pfizer has now recalled 345,000 bottles of Lipitor in the U.S., all with 40 mg tablets. However, one of our readers has observed the smell from bottles containing 80 mg tablets. The exact lots of 40 mg tablets included in the recall can be found on the company's web site.
We note that Pfizer has been running large newspaper ads promoting its co-pay card for Lipitor with no mention of the recalls. We think responsible companies should be advertising their recalls just as much as they do their sales.
Consumers should beware of any musty odors emanating from plastic bottles used for medicines. The odor problem is likely to expand beyond J&J's Tylenol and other OTC products and Pfizer's Lipitor. Until all sources of the odor are identified, we recommend you carefully and cautiously sniff each bottle of medication you open and report any musty or moldy odors to the manufacturer of the products as well as to the FDA.
—Don Mays
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