TBA (2,4,6 tribromoanisole), a byproduct of a chemical preservative commonly applied to wood used for pallets to move medicine boxes around in warehouses, has been found in some samples of Prezista, an HIV/AIDS medication. Consequently, J&J say they will recall the drug in several countries, including Germany, UK, Ireland, Austria and Canada.

The company says it is liaising with the regulatory authorities in five countries regarding this issue.

TBA has been the cause of several J&J recalls over the last couple of years, and the company appears unable to rid itself of this problem and other recall issues.

J&J’s international unit, Janssen-Cilag, received four complaints from customers who described an musty/moldy odor.

The company said it will recall and replace all affected Prezista bottles that are in the market. They say this involves no more than 2,000 bottles.

Consumers who experience any uncharacteristic odor coming from their Prezista 400mg or 600mg tablets should return them to their pharmacist and have them replaced immediately, Janssen-Cilag said.

Product recalls have spread to various parts of J&J, from OTC medication, surgical sutures to hip-replacement parts. Experts say the company’s once pristine reputation has been badly affected. J&J has shut down a factory outside Philadelphia, made management changes, and has also taken other measures – but is still dogged by problems, such as the one today. Since early 2010, over 300 million bottles and packages of consumer medicines, including pediatric ones, have been recalled.

The company stresses that TBA only has an unpleasant smell, it is not toxic and is not harmful to health. In some cases, patients may have mild gastrointestinal symptoms that soon disappear. In 2009 various OTC medications, including Tylenol had to be recalled because of TBA.

Canadian media report that one lot of 600 mg Prezista tablets contains some bottles with traces of TBA. Authorities in Canada do not believe the problem involved more than 300 bottles in Canada.

A J&J spokesman said “We do want to make it clear that patients should not stop taking their medication”. This recall does not include Prezista 75 mg and 300 mg tablets.

Prezista sales reached $857 million last year, a 45% increase on the year before.

The five affected lots of PREZISTA® 400 mg and 600 mg tablets are:

  • PREZISTA® (darunavir) film-coated TABLETS 600 mg Bottles of 60 Tablets
    Product code: 62058
    Lot number: ALZ0J00
    Expiry: November 2012
    Country: Canada
  • PREZISTA® (darunavir) film-coated TABLETS 400 mg Bottles of 60 Tablets
    Product code: 386333 and 386471
    Lot number: AKZ0B00 and AFZ0C00
    Expiry: May 2012
    Country: UK, Ireland
  • PREZISTA® (darunavir) film-coated TABLETS 600 mg Bottles of 60 Tablets
    Product code: 386332
    Lot number: ALZ0E00 and AKZ0D00
    Expiry: October 2012
    Country: Germany, Austria

Written by Christian Nordqvist