March 27, 2014 -- 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. 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.
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. "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."
alli is a turquoise blue capsule with a dark blue band imprinted with the text "60 Orlistat". It is 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 authentic product are shown here and available on the alli® website: www.myalli.com.
To date, some bottles bearing the following lot numbers and expiration dates on the carton have been reported to us by consumers as containing product other than alli:
- Carton Lot 14372, Expiration: 02/28/2016
- Carton Lot 14395, Expiration: 02/28/2016
- Carton Lot 14124, Expiration: 09/30/2015
- Carton Lot 14267, Expiration: 01/31/2016
- Carton Lot 14442, Expiration: 04/30/2016
These tampered products were reportedly purchased by consumers at retail stores in the following seven states: Alabama, Florida, Louisiana, Mississippi, New York, North Carolina and Texas.
Authentic alli® bottles have a tamper resistant seal.
The authentic seal is made of foil and has the authentic alli wording: "Sealed for your Protection." Counterfeit products may or may not have these features.
The authentic alli is a turquoise blue capsule with a dark blue band imprinted with the text "60 Orlistat".
A range of tablets and capsules of various shapes and colors were reported to be found inside counterfeit alli bottles.
This is the authentic 60mg alli 90 count carton.
The outer carton of counterfeit products may look authentic.
This is the authentic packaging for the 60mg alli 120 count product. The outer carton of counterfeit products may look authentic.
The same lot and expiration date codes should be printed on both the bottle label and the outer carton.
Authentic alli capsule packaging has a lot and expiration code.
The same lot and expiration date codes should be printed on both the bottle label and the outer carton.
The authentic alli bottle has a lot and expiration code that will match the packaging.
If The lot number and expiration date on the bottle do not match the lot number and expiration date on the outer carton -- it is counterfeit.
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