GlaxoSmithKline (GSK) Consumer Healthcare is voluntarily recalling all alli® weight loss products from U.S. and Puerto Rico retailers as the company believes that some packages of the product were tampered with and may contain product that is not authentic alli®, according to a March 27, 2014 FDA news release, "Glaxosmithkline Recalls Alli®."
Reports of tampering with the product, including some bottles that contain other pills, and fake tamper-resistant seals are in the news and posted as notices by the check out counters in some Sacramento supermarkets.
What customers found were tablets and capsules of various shapes and colors in purchased alli® containers. Alli is the only FDA approved, over the counter weight loss aid. Shoppers want to be sure what's on the label is what's in the container. In this case, tampering has occurred, and the item is being recalled.
The authentic drug is a turquoise-blue capsule. The tampering news broke on Wednesday, March 26, 2014. There have been no reports of any serious illnesses related to the product after news of the tampering, say the news articles on the tampering reports as of March 28, 2014. It's time to have independent laboratory testing to find out what's in those various types of pills and capsules.
Some bottles inside the outer carton were also missing labels and had tamper-evident seals that were not genuine. How are customers supposed to know in advance what a genuine tamper-evident seal looks like compared to a non-genuine tamper-evident seal, especially if they're buying the supplement for the first time?
GlaxoSmithKline (GSK) is conducting an investigation and is working with the knowledge of the U.S. Food and Drug Administration (FDA) on this retailer level recall, according to a March 27, 014 news release, "Glaxosmithkline Recalls Alli®," from the US Food and Drug Administration (FDA). GlaxoSmithKline is recalling all supplies of its non-prescription weight-loss drug called alli® in the United States and Puerto Rico after customers reported finding other pills and tablets in some bottles. Quality control problems are problematic in the pharmaceuticals industry. The company is a British group.
You also can check out recent news articles on this recall at Reuters, " GSK recalls weight-loss drug Alli in U.S. on tampering concerns," and at "GlaxoSmithKline recalls alli weight loss pills because of tampering."
GSK received inquiries from consumers in seven states about bottles of alli® that contained tablets and capsules that were not alli®
A range of tablets and capsules of various shapes and colors were reported to be found inside bottles. Additionally, some bottles inside the outer carton were missing labels and had tamper-evident seals that were not authentic. These tampered products were purchased in retail stores.
“Safety is our first priority and we are asking retailers and pharmacies to remove all alli from their shelves immediately,” said Colin Mackenzie, President Consumer Healthcare North America, according to the FDA's news release. “We have posted a Consumer Alert on our website, myalli.com, and issued a news release with information and photographs to help consumers determine if their alli is authentic.”
The product, alli® is a turquoise blue capsule with a dark blue band imprinted with the text “60 Orlistat”
It's packaged in a labeled bottle that has an inner foil seal imprinted with the words: “Sealed for Your Protection.” Consumers should confirm any alli® in their possession matches this description. Pictures of the product also are available on the myalli.com website.
Consumers who have product they are unsure or concerned about should not use it. Instead, they should call GSK promptly and a representative will provide further instructions. The phone number is listed on the FDA's news release about the recall, "Glaxosmithkline Recalls Alli®" or see "Recalls, Market Withdrawals, & Safety Alerts > Glaxosmithkline."
The FDA's recall notice explains that if shoppers have consumed the questionable product, they also should contact their healthcare providers. It's a retailer-level recall. Ironically, the product for sale in Europe was not affected by any tampering, according to news reports. Noteworthy is the fact that if someone has consumed the product and visited a physician, the physician would want to know what's in the product.
So lab testing of the tampered product could help. But in the case where different types of products were put into different containers, it's up to the consumer's physician to find out what's in the consumer's system. It goes back to the old adage that keeps asking in people's minds: What's in the container and who's testing it?
Retailers are recalling the product
“We are committed to finding out what happened and to doing everything possible to prevent future issues with alli®,” said Mackenzie, according to the FDA's news release. “We regret any inconvenience caused by this retailer recall.”
Also, hidden ingredients seem to be turning up in weight loss and various other types of supplements. See, "FDA warns consumers of hidden drug ingredients in weight loss supplements." Also check out, "FDA warns of hidden ibuprofen in Arth-Q joint supplement," and "Cleveland woman hospitalized with liver damage after taking OxyElite."
The site that explains what is supposed to be in the supplement notes that alli’s active ingredient, orlistat, is the most thoroughly studied weight loss drug in the world. Since its introduction in 1997, orlistat has been the subject of more than 100 clinical studies with some 30,000 patients. And in the real world, orlistat has been used by more than 50 million people.
Alli is the only FDA approved, over the counter weight loss aid, says the blurb on one photo of the product
The site explaining the product also explains that alli works in your digestive system by blocking some of the fat you eat. alli is only minimally absorbed into the bloodstream which means no direct effects on the cardiovascular system and the central nervous system so it won’t make your heart race or cause mood swings. These are just some of the reasons that alli is the only FDA-approved over-the-counter weight-loss aid.
But the main reason that alli has been successful for so many people is simple: alli works. Clinical studies have shown that for every two pounds you lose through diet and exercise, alli can help you lose one more. Check out the site, "Next: alli’s diet-related side effects." And see, "For full information, please see our FAQs." The site on the FAQs explain what the main active ingredient is in the product (when it's not tampered with).
The site notes, alli blocks about 25% of the fat you eat from being absorbed, and the fat that isn't absorbed is passed through your digestive tract
As a result, you may experience some bowel changes, particularly during the first few weeks of use. These diet-related side effects are most likely to occur after taking an alli capsule and eating a meal containing more than 15 grams of fat.
The sites on the product also advise the consumer to please see the company's frequently asked questions for more information on these diet-related side effects. The site advises shoppers that staying below your fat threshold lowers the chance of these alli side effects. Then the site adds, "if you do experience diet-related side effects, it may be because you've gone beyond your fat target." It's helpful to think of these effects as reminders from your body that you need to stick to lower-fat foods.
About alli® alli®
(60 mg orlistat capsules) is the only FDA approved over-the-counter weight loss aid clinically proven to help boost weight loss efforts. alli® is for weight loss in overweight adults, 18 years and older when used along with a reduced-calorie and low fat diet.
Consumer Healthcare GlaxoSmithKline Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. Its well-known brands include Nicorette® and NicoDerm® CQ, the leading smoking cessation products; alli®, the only FDA-OTC weight loss aid; as well as medicine cabinet staples, Aquafresh®, Sensodyne®, Tums®, and Breathe Right®, all of which are trademarks owned by and/or licensed to GSK Group of Companies.
About GlaxoSmithKline (GSK)
GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit the GSK site.