FDA MedWatch - Alli (60 mg orlistat capsules) by GlaxoSmithKline: Recall - Product Tampering

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Title: FDA MedWatch - Alli (60 mg orlistat capsules) by GlaxoSmithKline: Recall - Product Tampering
MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

Alli (60 mg orlistat capsules) by GlaxoSmithKline: Recall - Product Tampering

 

 

 

AUDIENCE: Consumer

ISSUE:  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 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.

BACKGROUND: Alli is for weight loss in overweight adults, 18 years and older when used along with a reduced-calorie and low fat diet. 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.”

RECOMMENDATION: Consumers who have product they are unsure or concerned about should not use it. Instead, they should call GSK promptly at 800-671-2554, and a representative will provide further instructions. If they have consumed questionable product, they should also contact their healthcare providers.

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm391013.htm


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