March 31, 2014 -- GlaxoSmithKline (GSK) Consumer Healthcare has voluntarily recalled all of its nonprescription weight loss drug alli from retailers in the United States and Puerto Rico, the company announced on March 27.
GSK says customers have reported that bottles of alli they purchased over the counter in retail stores contained tablets and capsules that were not alli. The company says it believes the bottles may have been tampered with.
Alli is a turquoise blue capsule with a dark blue band imprinted with the text "60 Orlistat." GSK says a "range of tablets and capsules of various shapes and colors" were reported to be found inside bottles.
Also, some bottles inside the outer carton were missing labels and had tamper-evident seals that were not authentic. Alli 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 of GSK Consumer Healthcare, tells Medscape Medical News by email.
The recall will pull alli from store shelves in 40,000 retail outlets across the U.S. and Puerto Rico, she says.
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 products other than alli:
February 28, 2016
February 28, 2016
September 30, 2015
January 31, 2016
April 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 of GSK Consumer Healthcare North America, says in a statement.
GSK is conducting an investigation and is working with the FDA. "We are committed to finding out what happened and to doing everything possible to prevent future issues with alli," Mackenzie says.
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 for further instructions. If anyone has taken a questionable product, they should contact their doctor, the company advises.
More information is available at www.myalli.com.