GSK recalls weight loss product Alli on tampering fears

GlaxoSmithKline has recalled all supplies of its over-the-counter weight loss medication Alli in the US and Puerto Rico after finding evidence of product tampering.

GSK and the US Food and Drug Administration (FDA) are looking into the problem while the retail-level recall takes place, and have warned the public not to use Alli in their possession if they believe it may have been interfered with or is not genuine.

Alli that shows evidence of being tampered with has been identified in seven US states so far, including Alabama, Florida, Louisiana, Mississippi, New York, North Carolina and Texas.

The company says customers reported that Alli bottles contained tablets that looked different to the genuine product - in "various shapes and colours" - while some bottles inside the carton were missing labels and had tamper-evident seals that were not authentic.

Alli takes the form of a turquoise blue capsule with a dark blue band imprinted with the text '60 Orlistat' and comes in labelled bottles with an inner foil seal bearing the phrase 'Sealed For Your Protection'.
 
"Safety is our first priority and we are asking retailers and pharmacies to remove all Alli from their shelves immediately," commented Colin Mackenzie, president of GSK's consumer healthcare business in North America.

All contains the active ingredient in Roche's prescription-only weight-loss drug Xenical, and GSK bought rights to the OTC product in 2004. Initial projections of $1bn-plus sales potential subsequently proved to be over-optimistic, and the product is estimated to add less than £100m a year to GSK's coffers.

The company offered the brand up for sale in 2011 along with other consumer health assets but failed to find a buyer. In the same year a Chinese national pleaded guilty to charges of trafficking in counterfeit versions of Alli in the US.

The company has been forced to take a number of actions to combat fake Alli products since the OTC product was launched; in 2010 for example it joined forces with eBay in 2010 to clamp down on illicit sales via the online marketplace.