NEWS AND PRESS

March 25, 2014 - GSK Reports alli® Product Tampering, Alerts Consumers to Unknown Product in alli® Packages

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

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 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                     

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 alli® Looks Like:

alli® 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: “Sealed for your Protection.” The same Lot and Expiration Date codes should be printed on both the bottle label and the outer carton. Check to make sure your alli® looks like this. Please see attached photos of an authentic alli® capsule, bottle with label and alli cartons below.

What Consumers Should Do:

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

- If you have consumed any product which you think may not be alli®, you should contact your healthcare provider. 

- GSK is seeking cooperation from consumers in this investigation. If you suspect you have purchased any inauthentic alli® 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.

For more information, see below:

Alli Product tampering

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.