GlaxoSmithKline is recalling all supplies of its over-the-counter weight-loss drug Alli (orlistat) in the United States and Puerto Rico after customers reported finding other pills and capsules in some bottles.
News of the tampering emerged on Wednesday. GSK received inquiries from consumers in Alabama, Florida, Louisiana, Mississippi, New York, North Carolina and Texas about 20 bottles containing tablets and capsules that were not Alli, Reuters reports. The British drug maker is working with the U.S. Food and Drug Administration (FDA) on the retail-level recall and to investigate the tampering.GSK said it was not immediately clear how the bottles had been tampered with or where in the supply chain the problem had occurred. Some bottles were missing labels and the tamper-evident seals were not authentic. Shoppers said they had found a variety of tablets and capsules of different shapes and colors in Alli containers. The authentic drug is a turquoise-blue capsule with a dark blue band imprinted with “60 Orlistat,” Alli’s active ingredient, CNN reports. A company spokeswoman said the investigation is ongoing. To date, there have been no reports of any serious illnesses related to the product, according to Reuters.
Alli, a low-dose version of Roche’s prescription drug Xenical, is an over-the-counter medication approved for use by overweight adults, in conjunction with a low-fat, low-calorie diet, Reuters reports. The drug assists in weight loss by preventing the absorption of fat. Alli was launched in the United States in 2007. In 2010 the FDA revised the labels of Xenical and Alli to include information about rare reports of severe liver injury in patients taking orlistat.
The drug is also sold in Europe, where no tampering problem has been detected, GSK said, and sales there are not affected by the U.S. recall.