NEWS AND PRESS

March 27, 2014 - GlaxoSmithKline Recalls alli®

MOON TOWNSHIP, Pa. – 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 product are available on our website: www.myalli.com.

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.

“We are committed to finding out what happened and to doing everything possible to prevent future issues with alli®,” said Mackenzie. “We regret any inconvenience caused by this retailer recall.”

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

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.

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 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

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.

For more information, see below:

QUESTIONS AND ANSWERS

We are initiating this voluntary retail level recall because we have determined that some alli® packages have been tampered with and may contain product that is not authentic alli®. A range of tablets and capsules of various shapes and colors have been reported to be found inside the bottles. Additionally, some bottles inside the outer carton had missing labels and tamper-evident seals that are not authentic. These tampered products were purchased in retail stores.

What does the tampered product look like?

·       The outer carton may look authentic.

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

·       The bottle may not have a label.

·       The bottle’s tamper evident seal may not be intact, not be made of foil and/or not have the authentic alli® wording: “Sealed for your Protection.”

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

To date, some bottles bearing the following lot numbers and expiration dates on the carton have been associated to us as containing product other than alli®.

Lot numbers and Expiration Dates:

·       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

What should consumers who have affected product do?

Consumers should look closely at their alli® and call us if they have concerns about their product. 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 product are available on our website: www.myalli.com. Consumers who believe they have questionable product or have any concerns should contact us promptly at 800-671-2554.

Is it safe to continue using alli®?

Consumers can use any authentic alli® they have in their possession. Authentic alli® is a turquoise blue capsule with a dark blue band, imprinted 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 product are available on our website: www.myalli.com. Consumers who believe they have questionable product or have any concerns should contact us promptly at 800-671-2554. If they have consumed questionable product, they should contact their healthcare providers.

Where were these tampered products purchased?

To date, these products were reportedly purchased by consumers at retail stores in the following seven states: Alabama, Florida, Louisiana, Mississippi, New York, North Carolina and Texas.

Is GSK working with regulatory agencies in the U.S.?

Yes. GSK has initiated an investigation and we are working with the knowledge of the U.S. Food and Drug Administration (FDA) on this voluntary retail level recall.

Have there been reports of suspected tampering or a recall in other markets?

To date, we have not received any reports of suspected tampering in other markets. No tampering reports have been received in areas outside the U.S. and the U.S. and Puerto Rico are the only markets launching a retail level recalls.

Has GSK received any consumer complaints related to this issue?

We received several consumer inquiries and we have initiated an investigation into what happened. Safety is our first priority.

How can consumers determine if they have product that has been tampered with?

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 product are available on our website: www.myalli.com.

Can I return unused product for a refund or replacement?

Consumers who think they may have questionable product should contact us promptly at 800-671-2554, and a representative will provide further instructions.

Are there other options for those who don’t want to use alli®?

alli® is the only FDA approved over-the-counter weight loss product. A balanced diet and physical activity remain the cornerstones of any healthy weight loss program. While consumers await a replenished supply of alli®, we encourage them to continue on their reduced calorie, low fat diet plan and to remain physically active. You can visit www.myalli.com for more information and tips on achieving a healthy weight loss.