U-Dream Recalled - Consumers Advised to Stop Consumption
The herbal sleep formula U-Dream is currently unavailable to Canadian retailers from distributors. Retail sales and distribution have been stopped indefinitely as a precautionary measure following a recall initiated by Health Canada.
We have been a retailer of U-Dream, we do not manufacture the product. Please do not call requesting more information regarding availability, there are no further updates available at this time. We have outlined the limited information provided to us below.
February 2020 Update: U-Dream manufacturer Biotrade issued a statement indicating that they are working with Health Canada in an effort to have their product licences reinstated and return their products to market. There is no known timeline as to when (or if) this might happen.
Testing of U-Dream by Health Canada and the U.S. FDA in late 2019 appears to have found 'Zopiclone impurity 22' - “a substance structurally similar to eszopiclone and zopiclone”. In response, the manufacturer of U-Dream Biotrade states: “note this is not the same as Zopiclone, a known pharmaceutical sleep aid (it is a similar molecule). Health Canada has confirmed and all our routine testing shows that Zopiclone is not present in the product.”
Health Canada and Biotrade are recommending that consumers (in consultation with their healthcare practitioner) stop consumption of U-Dream products immediately until further notice. Health Canada has requested Biotrade initiate the process of a recall via their distributors. Please contact your point of purchase for additional information on returns.
12/23/19 - Health Canada has issued a public statement about U-Dream after confirming to the manufacturer the results of their testing that found an analogue of zopiclone. They have suspended the natural product licences held by Biotrade.
“Health Canada is advising Canadians that it has tested several U-Dream Lite and U-Dream Full Night herbal sleep-aid products and has found that they contain a substance similar to the prescription drug zopiclone, which may pose serious health risks.”
In the United States, the Food and Drug administration issued a notice following testing of product there:
“FDA laboratory analysis confirmed that U-Dream Full Night contains a substance structurally similar to eszopiclone and zopiclone. Eszopiclone is the active ingredient in the FDA-approved prescription drug Lunesta, a controlled substance and a sedative-hypnotic (sleep) medicine used to treat insomnia in adults. Zopiclone is a sedative- hypnotic that has been promoted as a sleep aid in other countries but has not been approved by the FDA.”
Without NPN licenses from Health Canada, U-Dream products are likely to remain off the market for the foreseeable future. No date for when distribution might potentially resume is known.
Please see excerpts below from information provided by U-Dream's manufacturer Biotrade.
On November 21st, Biotrade Canada received a report from Health Canada regarding concerns they have with traces of an unidentified material detected in our U-Dream product. They are currently evaluating for any potential health risks. As a precautionary measure we are therefore voluntarily stopping distribution of the product immediately until such time as we can get further clarification from Health Canada on this concern and how they wish us to proceed.
At Biotrade Canada we put the safety and health of our consumers above all else. That is why we are working with Health Canada to take this action, to fully protect you our customer.
We know that our industry and retail partners share this priority and that our actions in this matter have been guided by this principle. In accordance with this, we are cooperating fully with Health Canada. We thank you for your patience as we work to resolve and address any concerns Health Canada has with the product.
CEO, Biotrade Canada
The current status of U-Dream is that Biotrade Canada has voluntarily stopped sales of the product in order to undertake further research and gather more data in regards to U-Dream's interactions with other supplements. Our recent research has shown that U-Dream taken with other medications with tranquilizing properties or that are depressors of the nervous system can have unwanted effects.
We are working closely with Health Canada to help ensure that they are also satisfied with the safety of the product.
The safety and trust of our customers is our highest priority. For this reason, we have decided to stop selling U-Dream and have asked all our retail partners to do the same. Please note: this is not a recall.
We are firmly committed to providing products of the highest possible quality and purity that truly benefit our customers. That is why U-Dream will be back on the market once we are satisfied with the results of our research and testings.
Unfortunately, we do not have a timeline for when the product will be available again but we are committed to getting it back in stores as soon as we can.
On December 17th, Health Canada formally indicated that they have found “Zopiclone impurity 22” in some batches of the U-Dream product. Please note this is not the same as Zopiclone, a known pharmaceutical sleep aid (it is a similar molecule). Health Canada has confirmed and all our routine testing shows that Zopiclone is not present in the product.
Health Canada has not given any indication regarding the amounts of the impurity in the product, if it poses any risks or whether it is of natural or manufactured origin. We are committed to doing whatever is required to identify the source of this material and remove it in order to return to stores for the well-being of the many people who benefit from the product. We are doing further testing and will keep you updated as soon as new information is available.
At Biotrade Canada we put the safety and health of our consumers above all else. Biotrade has no confirmed cases of related illness associated with the U-Dream product, however based on Health Canada's request we are recommending consumers stop consumption of the U-Dream products immediately until further notice.
Since receiving notification from Health Canada about the impurity allegedly found in our product, Biotrade Canada has been conducting an extensive investigation to confirm its existence and its source. This impurity was not previously known to us, and is not something we intentionally added.
Our team is preparing new samples of the product for testing. We are making changes to our production processes to provide a safe and effective product that satisfies Health Canada requirements. We are working with Health Canada to address their concerns in order to have our licence reinstated.
While we are not yet able to provide an estimated release date, our goal is to return U-Dream to stores as soon as possible.
We have been extremely busy in our quest to return this invaluable product back to the marketplace. Here is an update on where things currently stand.
As many of you are aware, Health Canada informed us of the suspension of the U-Dream product licenses at the end of 2019. Biotrade immediately complied with this directive and halted all product sales while continuing our extensive collaboration with medical and legal experts to resolve this issue in a timely manner.
In fact, since this time – and with the support of top industry experts – Biotrade has implemented significant changes that far exceed the licensing requirements now demanded by Health Canada standards.
Notwithstanding the fact that our new plan exceeds the legal requirements of the industry, Health Canada continues to deny the reinstatement of our product licenses. We would like to sincerely thank the hundreds of U-Dream customers who have sent glowing testimonials in support of this amazingly effective sleep remedy. While we regret that Health Canada’s action represents a considerable barrier to the reintroduction of this superior product, rest assured that Biotrade will continue to take all necessary action, both legal and otherwise, in our commitment to assist people to rebuild quality lives supported by a good and essential night’s sleep.
In short, Biotrade will continue to do everything possible to once more offer the safe, effective and natural sleep aid that so many of you have deemed the most reliable and effective sleep remedy ever introduced in Canada.
Health Disclaimer. First published 11/25/19, latest update 8/18/20. Copyright ©2019 Biotrade and Aviva. Published with permission.