This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.

GSK reports alliĀ® product tampering, alerts consumers to unknown product in alliĀ® packages

(Moon Township, PA) - March 26, 2014 ā€”

GlaxoSmithKline (GSK) is alerting consumers that some bottles of its alliĀ® over-the-counter weight loss medication have been tampered with. Consumer safety is GSKā€™s primary concern. We have initiated an investigation and are working with the Food and Drug Administration.

What does the tampered product look like:

Ā·         The outer carton may look authentic.

Ā·         The bottle may contain a range of tablets and capsules of various shapes and colors.

Ā·         The bottle may not have a label.

Ā·         The bottleā€™s tamper evident seal may not be intact, not be made of foil and/or not have the authentic alliĀ® wording: ā€œSealed for your Protection.ā€

Ā·         The lot numbers and expiration dates on the bottle do not match the lot number and expiration date on the outer carton.

Ā·         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 alliĀ®: 

    - 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

 

Where tampered product was found:

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.

 

What authentic alliĀ® looks like:

alliĀ® is a turquoise blue capsule with a dark blue band. It is packaged in a labeled bottle that has an inner foil seal imprinted with the words: ā€œSealed for your Protection.ā€ The same Lot and Expiration Date codes should be printed on both the bottle label and the outer carton. Check to make sure your alliĀ® looks like this.  Please see attached photos of an authentic alliĀ® capsule, bottle with label and alli cartons below.

 

What consumers should do:

Ā·         Consumers should not use the product if the authentic alliĀ® features as described above are not present, or if they have any concerns.

Ā·         If you have consumed any product which you think may not be alliĀ®, you should contact your healthcare provider.

Ā·         GSK is seeking cooperation from consumers in this investigation.  If you suspect you have purchased any inauthentic alliĀ® product, please promptly contact our Consumer Relations line at 800-671-2554 and a representative will provide you with further instructions. All product and packaging materials, including pamphlets, seals, etc. should be retained pending further instructions.

View authentic alliĀ® packaging here.

Media contact: Deborah Bolding (deborah.g.bolding@gsk.com) (412-327-5540)

About alliĀ®

alliĀ® (60 mg orlistat capsules) is the only FDA approved over-the-counter weight loss aid clinically proven to help boost weight loss efforts. alliĀ® is for weight loss in overweight adults, 18 years and older when used along with a reduced-calorie and low fat diet.

About GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. Its well-known brands include NicoretteĀ® and NicoDermĀ® CQ, the leading smoking cessation products; alliĀ®, the only FDA-OTC weight loss aid; as well as medicine cabinet staples, AquafreshĀ®, SensodyneĀ®, TumsĀ®, and Breathe RightĀ®, all of which are trademarks owned by and/or licensed to GSK Group of Companies.

About GlaxoSmithKline

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: http://www.gsk.com/.