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Glaxo recalls diet pills because of tampering

| Thursday, March 27, 2014, 1:45 p.m.

GlaxoSmithKline recalled a popular over-the-counter weight loss pill on Thursday, a day after the British drugmaker issued a warning that bottles of Alli had been tampered with and contained an unknown substitute.

The recall affected about 40,000 retail stores, said Deborah Bolding, a spokeswoman for Glaxo's Consumer Healthcare division in Moon. She could not say how many bottles were covered by the recall, how long it would take or what the cost would be.

Glaxo disclosed on Wednesday that customers in seven states reported finding evidence of tampering and strange pills in their Alli bottles. Glaxo and the Food and Drug Administration, which are investigating the tampering, said there have been no reports of anyone being harmed.

The recall is the latest setback for Alli. The company added a warning to the product in 2010 about the risk of liver damage. It warned consumers about counterfeit Alli being sold online. And Alli sales were hurt for several months in 2012 because the company couldn't get ingredients.

About 20 people reported buying Alli in the last five weeks that showed evidence of tampering, including missing seals, unlabeled bottles and mismatched lot numbers on bottles and carton packaging. The bottles that were tampered with had pills of various shapes and colors that were not Alli.

“Safety is our first priority, and we are asking retailers and pharmacies to remove all Alli from their shelves immediately,” Colin Mackenzie, president of Glaxo's North American Consumer Healthcare unit, said in a statement.

Alli is the only weight loss pill approved by the FDA for over-the-counter sales. Bolding said the problem of unknown pills showing up in Alli bottles was not the result of a manufacturing problem in the Aiken, S.C., plant where the drug is produced.

She was unable to provide further details of how or where the tampering may have occurred. She could not say what was substituted for Alli in the tampered bottles.

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.

Retailers across the country and in Puerto Rico have been instructed to pull the drug from shelves. Bolding declined to say what prompted Glaxo to issue a recall on Thursday and not the day before, when it first disclosed the problem, other than to say it reached the decision in collaboration with the FDA.

“The investigation is continuing. ... We're still gathering information,” she said. “We felt the appropriate next step was a recall.”

The company did not know how many bottles were covered by the recall, how long it would take or what the cost would be, Bolding said.

FDA spokeswoman Tara Goodin declined to comment, citing the ongoing investigation.

Alli is a turquoise blue capsule with a dark blue band imprinted with the text “60 Orlistat.” It helps people lose weight by blocking the absorption of fat in the intestines. Alli had American sales of about $153 million in 2009, the last year Glaxo reported sales for individual non-prescription drugs. Consumers who think they have purchased phony Alli should report it to Glaxo by calling 800-671-2554.

Tampered bottles were reported in Alabama, Florida, Louisiana, Mississippi, New York, North Carolina and Texas. The New York State Police has said it is investigating.

Bloomberg News contributed. Alex Nixon is a staff writer for Trib Total Media. He can be reached at 412-320-7928 or anixon@tribweb.com.

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