Pfizer expands Lipitor recall
pharmafile | December 24, 2010 | News story | Manufacturing and Production | Lipitor, Pfizer, manufacturing compliance, recalls
Pfizer has been forced to recall another 19,000 bottles of its cholesterol-lowering drug Lipitor in the US after consumers reported an unpleasant odour when opening the bottles.
While the cause of the smell has yet to be conclusively established, Pfizer said it was “consistent with the presence of 2, 4, 6 tribromoanisole (TBA)”, a chemical derived from a related compound called TBP which is used as a wood preservative. TBA was found in a bottle from the first recall of Lipitor earlier this year.
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, and the issue ranks among the top five most commonly-reported reasons for a product recall in the US during 2008-2010, according to Pharmafocus analysis.
The latest batch of 19,000 40mg bottles adds to around 375,000 bottles of Lipitor recalled by Pfizer since the August.
The earlier recall was linked to the use of wooden pallets by Rexam, which supplied the plastic bottles for the affected Lipitor batches Rexam has now reportedly changed its distribution practices to avoid the use of TBP-treated wood, and it is thought the latest recall concerns lots of the product distributed before that change.
“Although TBP often is applied to pallets used to transport and store a variety of products, Pfizer prohibits the utilisation of TBP-treated wood in the shipment of its medicines,” said the drugmaker in a statement.
Phil Taylor
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