MOON TOWNSHIP, Pa. — GlaxoSmithKline on Wednesday began 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," the company stated. "We have initiated an investigation and are working with the Food and Drug Administration."
The outer carton of any tampered product may look authentic, but there are several tell-tale signs that the product has been tampered with, GSK cautioned, including:
- 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."; and
- 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 GSK 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; and
- Carton Lot 14442, Expiration: 04/30/2016.
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 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.
Consumers should not use the product if the authentic Alli features as described above are not present, or if they have any concerns, GSK cautioned. "If you have consumed any product which you think may not be Alli, you should contact your healthcare provider," GSK stated.
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."