Weight-Loss Drug Alli Recalled By GlaxoSmithKline

London-based GlaxoSmithKline Plc (GSK) has issued a recall in the United States and Puerto Rico for Alli, its weight-loss drug, due to consumer complaints received from seven states. In a statement, Glaxo said that it has received reports of customers opening bottles containing multi-colored tablets in various shapes and sizes, instead of the regular turquoise capsule.

The company said that there was evidence of tampering in some of the packaging, and some bottles had missing labels or inauthentic seals. This is the second major setback for the drug maker on its weight-loss product. In 2010, the company was forced to add a warning about the risks Alli, an over-the-counter product, posed to the liver. Working in conjunction with the FDA, Glaxo is investigating the suspected product tampering, it reports.

Glaxo’s Colin MacKenzie, president of North American consumer health-care division, said, “Safety is our first priority and we are asking retailers and pharmacies to remove all Alli from their shelves immediately. We have posted a Consumer Alert on our website, www.myalli.com, and issued a news release with information and photographs to help consumers determine if their Alli is authentic.” Consumer complaints about the suspected tampering have come from Alabama, Florida, Louisiana, Mississippi, New York, North Carolina and Texas, reports Glaxo.

In 2011, the pharmaceutical company said that it would attempt to sell its portfolio of consumer brands that are relatively slow-growing, including Alli. In 2012, it changed course saying that it would instead retain Alli in its portfolio.

In 2009, the last year that Glaxo reported sales figures by individual consumer product, sales of Alli totaled $338 million. Alli contains the chemical agent orlistat and works to support weight loss by blocking the mechanism in the intestines. Product information says the pill can be taken up to three times per day at mealtime.