Johnson & Johnson has been hit by another product recall, with two lots of its antipyschotic Risperdal being pulled due to an “uncharacteristic odour”.
J&J has initiated the voluntary recall of one lot of Risperdal (risperidone) 3mg tablets, consisting of 16,000 bottles marketed by its Janssen division, and another 24,000-bottle lot of risperidone 2mg sold by the healthcare giant’s Patriot Pharmaceuticals. The move was prompted by two consumer reports of a nasty smell thought to be caused by trace amounts of TBA (tribromoanisole) a byproduct of a chemical preservative applied to wood used on pallets.
While not considered to be toxic, TBA can generate “an offensive odour and a very small number of patients have reported temporary gastrointestinal symptoms when taking other products with this odour”, J&J said. The company noted that there have been no reported serious adverse events caused by the presence of TBA and in January 2010, it required suppliers to certify that they do not use pallets made from chemically-treated wood.
J&J believes that around 2,800 bottles from the lots remaining in the marketplace and does not anticipate a product shortage. However, the recall is the latest in a number of cases which has seen a number of J&J treatments being pulled from the market.
Last month, 2,000 bottles of HIV drug Prezista (darunavir) were recalled in the UK, Germany, Ireland, Austria and Canada due to the TPA odour issue and in April, some 57,000 bottles of the epilepsy treatment Topamax (topiramate) were pulled because of the smell. Also here have been thousands of recalls of over-the-counter medicines, including the children’s analgesic Tylenol and Benadryl allergy tablets, which have also had an odour problem.
