OTTAWA, May 16, 2014 /CNW/ -
One lot of Lite Fit USA (Lot Number 13165, Exp. 05/17) is being
voluntarily recalled in the U.S. after analysis by the U.S. Food and
Drug Administration revealed the lot contains the undeclared
prescription drug sibutramine. Lite Fit USA is not authorized for sale
in Canada, but Health Canada has confirmed that this lot was imported
and sold by the retail store Hoang Oanh Sandwich, 7178 St. Denis,
Montreal, Québec. The affected lot may also be available at other
retail outlets or for purchase online. Products that contain
sibutramine are not authorized for sale on the Canadian market due to
an increased risk of heart attack and stroke.
LiteFit USA is promoted as a herbal diet supplement packaged in plastic
bottles of 30 softgels (see photo below).
Who is affected:
Canadians who either have used or purchased Lite Fit USA, lot number
What consumers should do:
Read the label of the products you buy to verify that they have been
assessed by Health Canada for safety, effectiveness and quality. Health
products that have been authorized for sale by Health Canada will have
an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine
Number (DIN-HM) or a Natural Product Number (NPN) on the label.
Contact your health care practitioner if you have any questions or
concerns regarding the use of this product.
What Health Canada is doing:
Health Canada is contacting drug importers to prevent any further
importation or distribution of Lite Fit USA in Canada. Health Canada is
also working with Canada Border Service Agency to help prevent future
importations of LiteFit USA.
Sibutramine was previously used to treat obesity but is no longer authorized for
sale in Canada because of its association with an increased risk of
cardiovascular side-effects such as heart attack and stroke. The
product poses a risk to consumers because sibutramine is known to
substantially increase blood pressure and/or pulse rate in some
patients and may present a significant risk for patients with a history
of cardiovascular disease including coronary artery disease, congestive
heart failure, arrhythmias, or stroke. This product may also cause
serious side-effects in pregnant or nursing women. Sibutramine can
interact with other medications and herbal products and poses a risk of
serotonin syndrome, a serious and potentially fatal event.
Health Canada has not received any adverse reactions reports associated
with the use of this product.
1. Lite Fit USA (Lot Number 13165).
For more information:
Consumers and health professionals wanting more information about this
advisory from Health Canada can contact the Public Enquiries Line at
613-957-2991, or toll free at 1-866-225-0709.
Media enquiries related to this Advisory should be directed to Health
Canada Media Relations at 613-957-2983.
How to report side effects of health products to Health Canada:
Call toll-free at 1-866-234-2345
Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
Stay connected with Health Canada and receive the latest advisories and
product recalls using social media tools.
PDF available at: http://stream1.newswire.ca/media/2014/05/16/20140516_C8906_DOC_EN_40459.pdf
SOURCE: Health Canada
For further information:
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