GSK, FDA investigate tampering incident of the Alli weight-loss product

Voluntary recall of all products in the US and Puerto Rico has begun

The story broke Wednesday, March 26, that 20 consumers, in seven states (AL, FL, LA, MS, NY, NC and TX) had reported obtaining bottles of the weight-loss product Alli (orlistat) from retail outlets that contained differently colored pills and broken tamper-evident seals. At first, it wasn’t clear that this is a case of counterfeit or tampering, but by the next day, a GSK spokesperson indicated that “It’s a tampering incident.” According to the company, Alli, an OTC product, is sold in 40,000 retail outlets in the US and Puerto Rico; a voluntary recall of all products in inventory at retailers has begun. (Think about the cost of retrieving product from 40,000 stores!) This isn’t the first time this has happened; the product suffered a counterfeiting scheme in 2010.

Authentic Alli is blue capsules, packaged in a bottle with a foil seal imprinted with the words “Sealed for Your Protection.” The suspect packages contained tablets or capsules of various colors, and the seal may or may not be unbroken, and may or may not include the imprinting. Also, lot numbers and expiration dates on the bottle do not match those on the outer carton.

It’s only speculation at this point, but this incident looks similar to the infamous Tylenol attack in the 1980s, where Tylenol packages were contaminated with cyanide on store shelves, resulting in seven deaths (the current Alli problem has NOT resulted in any deaths or injuries, according to GSK’s current information). Those cases were all in the Chicago area, while this one covers multiple states, which points to a supply-chain intrusion. The Tylenol incident was never solved, but led to the practice of applying tamper-evident seals and other protective measures.