FDA Warns Consumers about Counterfeit Alli : RushPRNews - Newswire & Global Press Release Distribution

 
Bookmark and Share

FDA Warns Consumers about Counterfeit Alli

January 19, 2010

Washington, DC (RPRN) 01/19/10 — The counterfeit products contain controlled substance sibutramine

The U.S. Food and Drug Administration is today warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).

Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)—the maker of the FDA approved over-the-counter weight-loss product— revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking.

Consumers began reporting suspected counterfeit Alli to GSK in early December 2009. GSK has determined that the counterfeit product has been sold over the internet. However, there is no evidence at this time that the counterfeit Alli product has been sold through other channels, such as retail stores.

The counterfeit Alli product looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:

Outer cardboard packaging missing a “Lot” code;

Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);

Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;

Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION”;

Contains larger capsules with a white powder, instead of small white pellets.

Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these counterfeit products to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

 

Media Web Address: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197857.htm
About the author:

FDA is an agency within the Department of Health and Human Services and consists of seven centers and offices

Click here to see all news from this author/company

Filed Under: FDA- Pharmaceutical news, Health and Fitness, Lifestyle, PRESS RELEASE

RUSH PR NEWS newswire and press release services at rushprnews.com / Anne Howard annehowardpublicist.com

Content- Legal Responsibility - All material is copyrighted - You may repost but you MUST link back to the original post on your page and acknowledge Rush PR News as the news source. Rush PR News is not legally and/or morally responsible for content of press releases, opinions expressed or fact-checking.

Rush PR News cannot be held legally responsible for material published and distributed through its newswire service or published in its press-room and therefore cannot be sued for published material. Third-party must be contacted directly to dispute content.

Rush PR News is not the contact for material published.

RSSFeed PRESS & SOCIAL MEDIA RELEASES

GeneSegues Therapeutics Awarded Contract For Development of Nanocapsule-based Vaccine for Biodefense Pathogen

MINNEAPOLIS, MN 12/18/14 · Company Collaborating With U.S. Army Researchers on Topically...

Enjoy a Virtual Tour of Canada's Favourite Spa

GRAFTON, ON 12/16/14 · A brand new tour of Ste. Anne's Spa...

Bahama Beach Club Hosts Christmas and 12th New Year’s Eve Party

Treasure cay 12/13/14 · If you're looking for the perfect place to...

Opportunistic Brand Savvy Investors set to snap up Stackcap Patent

London, UK 12/11/14 · Business savvy investors welcomed an exciting opportunity this...

Newborn Foundation Applauds Reauthorization of Newborn Screening Saves Lives Act

WASHINGTON, D.C. 12/11/14 · The U.S. House of Representatives has passed H.R....

SecurifyApp makes it safe to be Home Alone during this holiday season

New York, New Yrok 12/10/14 · More Americans fall victim to accident, theft and...

Routehappy Raises $3.3M in Funding to Expand Airline & Distributor Products

NEW YORK 12/10/14 ·  -- Routehappy, the product differentiation platform for air travel,...

Spa Lovers Select Ste. Anne's as Canada's Top Destination... Again!

GRAFTON, ON 12/04/14 · Spafinder Wellness once again has awarded Ste. Anne's...

Who Couldn`t Use a Hug? Announcing the HugTrain 6th Annual Hug Tour Dec 2014

Montreal, Quebec, Canada 12/03/14 · Cross Continental Canadian-U.S. Train Journey to Raise Spirits...

Zikto announces stretch goals for successful Kickstarter campaign

Los Angeles/Seoul, Korea 12/01/14 · Campaign reaches global audience! Riding high on the accomplishment...

Coffee With Dr. Stewart

Austin, TX 11/25/14 · A brother and sister bring an exciting new...

Arki Kickstarter reaches $100K target in 13 days

Los Angeles/Seoul, Korea 11/24/14 · One step closer to a walking revolution The kickstarter...

Zikto taking award-winning Arki to Startup Nations Summit

Seoul, Korea 11/22/14 · Zikto taking award-winning Arki to Startup Nations Summit The...

The End of Transparency? Don't be a fraud target

Carrollton, TX 11/18/14 · - Over the years, progressive and productive societies...