Pfizer recalls Lipitor tablets because of ‘musty’ smell
pharmafile | October 22, 2010 | News story | Manufacturing and Production | Lipitor, Pfizer, pharma recalls, product recalls
Pfizer has recalled 191,000 bottles of its cholesterol drug Lipitor in the US after customers complained of an unusual, musty smell.
The cause of the smell has been identified as 2, 4, 6 tribromoanisole or TBA, a chemical which was also implicated in the January 2010 recall of millions of over-the-counter products by Johnson & Johnson, according to an FDA enforcement report.
TBA is a fungal metabolite of the related chemical 2,4,6-tribromophenol (TBP), which is used as a flame retardant and wood preservative.
At the time of its recall, J&J said the smell was caused by leaching of the chemical into the products from wooden pallets used during their shipping and storage, but as yet there is no suggestion that the affected Lipitor batches have been affected by the same problem.
Pfizer said it had received three consumer complaints about the odour in July, including one adverse event report, but said there was nothing to indicate that patients could be harmed by ingesting the affected Lipitor.
The recall, which was initiated in mid-August, involves Lipitor (atorvastatin calcium) 40mg tablets in 90-count bottles from five US lots, all of which are due to expire in January 2013. Another five lots distributed to Canada are also subject to recall.
According to the FDA recall notice the affected lots were manufactured by Pfizer facilities in Ireland (Ringaskiddy) and Germany (Freiburg) and presented in bottles supplied by packaging giant Rexam,
The recall is not expected to lead to any shortages of Lipitor, as there are an estimated 4.6 million bottles of the product in circulation in the USA. The brand had sales of more than $11 billion last year.
Phil Taylor
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