FDA Warns Consumers about Counterfeit Weight-Loss Product

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The FDA has issued a warning to consumers about a counterfeit and possibly harmful version of Alli 60 mg capsules (120 count refill kit). Alli is an over-the-counter weight-loss product.

Preliminary laboratory tests conducted by GlaxoSmithKline, which makes Alli, showed that the counterfeit version did not contain the active ingredient orlistat, but instead contained the controlled substance sibutramine, according to an FDA press release. Sibutramine can interact in an adverse way with other medications individuals might be taking.

Counterfeit and authentic Alli appear similar, but the counterfeit product differs in that it has outer cardboard packaging missing a “lot” code, an expiration date that includes the month, day, and year (authentic Alli's expiration date includes only the month and year). The counterfeit product contains larger capsules with a white powder instead of small white pellets and it is packaged in a plastic bottle that has a slightly taller and wider cap with coarser ribbing that the authentic product.

GSK has determined that the counterfeit product has been sold over the Internet, but so far there is no evidence that it has been sold through other channels, such as retail stores, the FDA said.

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