US health care major Johnson & Johnson (J&J) is recalling another lot of Tylenol because of a musty or mouldy odour, the sixth time in less than a year that the $62-billion drug giant has felt compelled to issue recalls for the over-the-counter painkiller.
In a statement, J&J's McNeil Consumer Health division announced that it was recalling about 128,000 bottles of 50-count bottles of Tylenol 8-hour caplets in the US and Puerto Rico.
McNeil said that is was resorting to the recall following a small number of complaints of a musty or mouldy odour. The New Jersey-based drugmaker feels that the uncharacteristic odour is thought to be caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole.
The company said that the voluntary recall is being made as a precaution and the risk of adverse medical events is remote. It added that the complaints for this lot were temporary and non-serious.
The recalled lot was made in March at McNeil's plant in Fort Washington, Pennsylvania, which was shut down the following month to rectify the problem as required by the US Food and Drug Administration (FDA).
Similar complaints in December 2009 had led J&J to recall lots of Tylenol. At the time the FDA said the cause of the problem was the breakdown of a certain chemical applied to the wooden pallets used to ship the product.