Counterfeit Alli Missing Lot Codes, Other Authentic Packaging Elements

FDA is warning consumers about counterfeit Alli reportedly sold over the Internet. Testing by manufacturer GlaxoSmithKline has revealed that the fake products contain the controlled substance sibutramine, not contain orlistat, the active ingredient in its product. FDA warns that this fake version of Alli 60 mg capsules (120 count refill kit) could be harmful if used improperly.

While the counterfeit Alli product looks similar to the authentic product, there are "a few notable differences" in its packaging, FDA reports. According to the agency, the counterfeit Alli has:

* Outer cardboard packaging missing a “Lot” code;
* Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);
* Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;
* Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION”;
* Contains larger capsules with a white powder, instead of small white pellets.

Consumers began reporting suspected counterfeit Alli to GSK in early December 2009. GSK has found no evidence that the counterfeit products were sold at retail outlets. Concerned consumers are advised to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

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