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Another 38,000 bottles of the Pfizer’s cholesterol drug Lipitor have been recalled, adding to the 190,000 recalled earlier this year, because of reports of a foul odor linked to the packaging bottles. The recall affects Lipitor 40 mg tablets (atorvastatin calcium) distributed in the United States and supplied by a third-party manufacturer.
Lipitor is used along with diet, exercise and weight-loss to reduce cholesterol and thus, the risk of heart attack and stroke and to decrease that the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.
Pfizer says it has investigated the source of the odor and determined it to be “episodic exposure of the bottle to low levels of TBA (tribromoanisole) as they were shipped or stored.” Tribromoanisole is a chemical used as a wood preservative that has a characteristically moldy smell and can cause vomiting and diarrhea if ingested. It is the same chemical that caused the foul smell in bottles of Tylenol and which resulted in the recall of millions of Johnson & Johnson over-the-counter drugs, including the popular pain killer Tylenol.
No adverse events have been reported to the Food and Drug Administration (FDA), and Pfizer claims the risk of health consequences to patients is minimal. But the FDA fears the foul odor may cause patients to stop taking their medication. The agency urged patients using Lipitor to consult their healthcare provider before discontinuing use of their medication.
Pfizer says it does not expect a product shortage as a result of the recall, however customers with questions may call the manufacturer at 1-888-LIPITOR.
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