Diet Drug Orlistat (alli) Recalled in US Over Tampering

Megan Brooks

Disclosures

March 28, 2014

GlaxoSmithKline (GSK) Consumer Healthcare has voluntarily recalled all of its nonprescription weight-loss drug orlistat (alli) from retailers in the United States and Puerto Rico, the company announced March 27.

GSK said customers have reported that bottles of orlistat they purchased over the counter in retail stores contained tablets and capsules that were not orlistat.

Orlistat is a turquoise blue capsule with a dark blue band imprinted with the text "60 Orlistat." GSK said a "range of tablets and capsules of various shapes and colors" were reported to be found inside bottles.

In addition, some bottles inside the outer carton were missing labels and had tamper-evident seals that were not authentic. Orlistat is packaged in a labeled bottle that has an inner foil seal imprinted with the words, "Sealed for Your Protection."

"We have received reports of about 20 bottles purchased by 12 consumers in 7 states: Alabama, Florida, Louisiana, Mississippi, New York, North Carolina, and Texas. We have had no reports of serious side effects," Deborah Bolding, senior external communications manager, GSK Consumer Healthcare, told Medscape Medical News by email.

"The recall will pull alli from store shelves in 40,000 retail outlets across the US, as well as in Puerto Rico," she said.

In a consumer alert issued March 26, GSK said some bottles bearing the following lot numbers and expiration dates on the carton have been reported containing product other than orlistat:

Table. Lot and Expiration Date

Carton Lot Expiration Date
14372 February 28, 2016
14395 February 28, 2016
14124 September 30, 2015
14267 January 31, 2016
14442 Apri 30, 2016

"Safety is our first priority and we are asking retailers and pharmacies to remove all Alli from their shelves immediately," Colin Mackenzie, president Consumer Healthcare North America, said in a statement.

GSK is conducting an investigation and is working with the knowledge of the US Food and Drug Administration on this retailer-level recall. "We are committed to finding out what happened and to doing everything possible to prevent future issues with Alli," Mackenzie said.

GSK is advising consumers who have purchased alli not to use it if they are "unsure or concerned" about the authenticity of the product. Instead, they are asked to call GSK at 800-671-2554, and a representative will provide further instructions. If anyone has consumed questionable product, they should contact their healthcare provider, the company advises.

More information is available at http://www.myalli.com.

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