Pfizer pulls more Lipitor over odour problem
pharmafile | November 2, 2010 | News story | Manufacturing and Production |ย ย Lipitor, Lipitor recall, Pfizer, manufacturing compliance, recallsย
Pfizer has widened its Lipitor recall after yet another incident in which consumers reported a musty smell emanating from bottles of the cholesterol drug.
The latest recall involves an additional two lots of Lipitor (atorvastatin calcium) – affecting around 38,000 bottles distributed in the US – and comes on top of two earlier recalls affecting a total of around 330,000 bottles in August and October.
One again the culprit appears to be 2,4,6 tribromoanisole or TBA, a metabolite of the related chemical 2,4,6-tribromophenol (TBP), which is used as a flame retardant and wood preservative.
This is the latest in a string of cases in which the chemical has leeched into pill bottles from the wooden pallets used to transport and store them. Similar odour problems led to recalls at Johnson & Johnson earlier this year.
In a statement, Pfizer said the smell is consistent with TBA “which was found at a very low level in a complaint sample bottle during the investigation leading to the first product recall”. The latest recall applies to product that was packaged before the original TBA problem was encountered, it added.
Pfizer also said its policy is to prohibit the use of pallets made using TBA-treated wood in shipping of its products, and that it plans to start requiring bottle manufacturers to switch to plastic pallets instead of wood to prevent the problem recurring.
Phil Taylor
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