Glaxo recalls diet pills because of tampering
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 firstname.lastname@example.org.
Add Alex Nixon to your Google+ circles.
Show commenting policy
TribLive commenting policy
You are solely responsible for your comments and by using TribLive.com you agree to our Terms of Service.
We moderate comments. Our goal is to provide substantive commentary for a general readership. By screening submissions, we provide a space where readers can share intelligent and informed commentary that enhances the quality of our news and information.
While most comments will be posted if they are on-topic and not abusive, moderating decisions are subjective. We will make them as carefully and consistently as we can. Because of the volume of reader comments, we cannot review individual moderation decisions with readers.
We value thoughtful comments representing a range of views that make their point quickly and politely. We make an effort to protect discussions from repeated comments either by the same reader or different readers.
We follow the same standards for taste as the daily newspaper. A few things we won't tolerate: personal attacks, obscenity, vulgarity, profanity (including expletives and letters followed by dashes), commercial promotion, impersonations, incoherence, proselytizing and SHOUTING. Don't include URLs to Web sites.
We do not edit comments. They are either approved or deleted. We reserve the right to edit a comment that is quoted or excerpted in an article. In this case, we may fix spelling and punctuation.
We welcome strong opinions and criticism of our work, but we don't want comments to become bogged down with discussions of our policies and we will moderate accordingly.
We appreciate it when readers and people quoted in articles or blog posts point out errors of fact or emphasis and will investigate all assertions. But these suggestions should be sent via e-mail. To avoid distracting other readers, we won't publish comments that suggest a correction. Instead, corrections will be made in a blog post or in an article.
- Heinz merging with Kraft in mega-deal; headquarters to stay in Pittsburgh
- If you get this letter from the IRS, it’s legitimate
- Corporate missteps hurt reputations, profits, sometimes in long run
- France plane crash victim’s father calls for airlines to focus on pilot welfare
- Farmers fund research on gluten-free wheat
- Stafford: Hirers bemoan wasted time with some applicants
- Home appraisal is below sales price — now what?
- Venting online about job protected
- Komando: Boost cellphone signal when nixing landline
- Loss of Costco staggers credit card giant
- Tourists rush to visit Cuba before American influence felt