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Glaxo Recalls Diet Drug Alli in U.S. on Tampering Concern

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March 27 (Bloomberg) -- GlaxoSmithKline Plc is recalling its weight-loss drug Alli in the U.S. and Puerto Rico after receiving complaints from consumers in seven states.

The customers reported that bottles contained tablets and capsules of various shapes and colors, rather than the usual turquoise blue capsule, London-based Glaxo said in a statement. Some packages were tampered with and some bottles had missing labels and seals that weren’t authentic, the company said.

The recall marks another setback for Glaxo on Alli, which has been linked to reports of liver injury. Glaxo added a warning about liver risks to the over-the-counter product in 2010. The company also had ingredient supply disruptions with Alli in 2012, almost eliminating sales over a quarter. Glaxo said it’s conducting an investigation and working with the U.S. Food and Drug Administration on the suspected tampering.

“Safety is our first priority and we are asking retailers and pharmacies to remove all Alli from their shelves immediately,” said Colin Mackenzie, president of Glaxo’s North American consumer health-care division. “We have posted a Consumer Alert on our website, www.myalli.com, and issued a news release with information and photographs to help consumers determine if their Alli is authentic.”

Dozen Complaints

Reports about possible tampering came from about a dozen consumers who had bought 20 bottles in Alabama, Florida, Louisiana, Mississippi, New York, North Carolina and Texas, said spokeswoman Deborah Bolding by phone. No serious illness has been reported from the customers, she said.

The reports started about five weeks ago and have picked up more recently. Alli is produced at a Glaxo factory in Aiken, South Carolina, and it’s unclear at which point in the supply chain the tampering occurred, Bolding said. The company is still investigating contents of the reported bottles, she said.

The missing labels and irregular seals suggest that the tampering occurred somewhere along the distribution network, said Jan Van Mieghem, a supply-chain expert and professor of managerial economics at Northwestern University.

After the product leaves the factory, it may be sent to wholesalers, and there may be three or four stocking points before it reaches pharmacy shelves. In between, transportation and logistics may have been outsourced to third parties, he said.

‘Own the Problem’

Still, “Glaxo has to own the problem,” Van Mieghem said by phone. Glaxo declined to provide details on its distribution system, citing concerns that disclosure would compromise security.

The FDA hasn’t received any notifications of adverse events pertaining to Alli through its reporting system, spokeswoman Tara Goodin said by e-mail.

Glaxo said in 2011 it would try to sell Alli along with other slow-growing consumer brands. A year later, the company said it would keep the product in its portfolio.

Sales of the weight-loss pill totaled 203 million pounds ($338 million) in 2009, the last year Glaxo broke out revenue for individual consumer products. The product is sold in more than 40,000 U.S. retail outlets, according to the company.

Alli contains orlistat, a chemical that blocks the intestines from absorbing fat when taken as many as three times a day with meals.

To contact the reporter on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net

To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net Kristen Hallam, Ben Livesey