Welcome!

News Feed Item

Herbal Detox and Laxative Products Formule L1 and Detox Spring Fall Recalled Due to Missing Risk Statements on Label

OTTAWA, ONTARIO -- (Marketwired) -- 02/27/14 -- The issue:

Health Canada is informing Canadians that Les Importations Herbasante Inc. is voluntarily recalling Formule L1 and Detox Spring-Fall because the labels are missing important risk statements, including the contraindications and warnings associated with the use of these products. In addition, the two products are being sold in a single package and pose an increased risk to health when used together.

To date, Health Canada has not received any reports of adverse drug reactions related to the use of these products.

Who is affected:


--  Canadians who have purchased or have used these products and need to be
    aware of the important cautions, warnings and contraindications
    associated with these products.

What Consumers should do:


--  Consumers should be aware of the risks associated with these products.
    The complete list of cautions, warnings and contraindications associated
    with these products can be found in the Background section of this
    advisory.

--  If you have used these products and are concerned about your health,
    please consult your healthcare practitioner.

--  Consumers are also encouraged to return the products to the place of
    purchase or call Les Importations Herbasante Inc. at 1-800-446-4242.


What Health Canada is doing:

Health Canada is monitoring the recall of the affected products and will continue to provide updates, as warranted.

Background:

Formule L1 is sold as a herbal laxative and Detox Spring-Fall as a diuretic (water pill). These two products are being sold in a single package.

Detox Spring-Fall should not be used in combination with Formule L1, as Formule L1contains a laxative. The use of these products together may cause severe dehydration.

The complete list of cautions, warnings and contraindications associated with these products is listed below:

Formule L1 Risk Information:

Cautions and Warnings

Consult a health care practitioner if symptoms persist or worsen. Consult a health care practitioner if raised intraocular pressure or edema occurs. Consult a health care practitioner prior to use if you have a kidney disorder or are taking prescription medication (e.g. cardiac glycosides or antiarrhythmic medications); if you have faecal impaction or symptoms such as abdominal pain, nausea, vomiting or fever; if you have gallstones. Reduce dose or discontinue use if you experience abdominal pain, cramps, spasms, and/or diarrhea. Consult a health care practitioner prior to use if you are taking thiazide diuretics, corticosteroids, licorice root or other medications or health products that may aggravate electrolyte imbalance.

Contraindications

Do not take if you are pregnant or breastfeeding. Do not take if you are using anticoagulant or antiplatelet medication; if you are allergic to plants of the Asterceae/Compositae/Daisy family; if you have a bile duct obstruction. Do not use if you have abnormal constrictions of the gastrointestinal tract, potential or existing intestinal blockage, atonic bowel, appendicitis, inflammatory colon disease, abdominal pain of unknown origin, undiagnosed rectal bleeding, severe dehydration with depleted water or electrolytes, hemorrhoids or diarrhea.

Known Adverse Reactions

Hypersensitivity, such as allergy, has been known to occur; in which case, discontinue use.

Detox Spring-Fall Risk Information:

Cautions and Warnings

Consult a health care practitioner before using if you are pregnant or nursing, if you suffer from diabetes or have liver problems. Consult a health care practitioner if symptoms persist or worsen. Discontinue use and consult a health care practitioner immediately if you experience dizziness, vertigo, mental confusion, muscular weakness or pain, an irregular heart beat and/or difficulty breathing.

Contraindications

Do not use if you are allergic to plants of the Asteraceae/Compositae/Daisy family. Do not use if you have liver or gallbladder problems, or an intestinal obstruction. Discontinue use if you experience symptoms of liver problems. Do not use if you suffer from stomach irritation or acute stomach inflammation, or a gastric or duodenal ulcer. Do not use if you are taking thiazide diuretics, cardiac glycosides, corticosteroids, stimulant laxatives or other medications or health products that may aggravate electrolyte imbalance. Do not use if you have hypokalemia, high blood pressure, or cardiovascular or kidney problems. Do not use if you are dehydrated. Do not use if you suffer from heart, kidney or liver problems, high or low blood pressure, or oedema (swelling of hands, face or feet) or if you take products that contain diuretics.

Known Adverse Reactions

Hypersensitivity, such as allergy, has been known to occur; in which case, discontinue use. Some people may experience headaches.

Products recalled/affected:

Formule L1, sold co-packaged with Detox Spring Fall (24 Detox ampoules + 36 Formule L1 capsules)

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.

More information is also available from Les Importations Herbasante Inc. by calling 1-800-446-4242.

How to report side effects to health products to Health Canada:

Provide relevant details about how to report adverse reactions / problems / concerns, eg.:

- 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.

Egalement disponible en francais

Contacts:
Media Enquiries:
Health Canada
(613) 957-2983

Public Enquiries:
(613) 957-2991
1-866 225-0709

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
Fifty billion connected devices and still no winning protocols standards. HTTP, WebSockets, MQTT, and CoAP seem to be leading in the IoT protocol race at the moment but many more protocols are getting introduced on a regular basis. Each protocol has its pros and cons depending on the nature of the communications. Does there really need to be only one protocol to rule them all? Of course not. In his session at @ThingsExpo, Chris Matthieu, co-founder and CTO of Octoblu, walked through how Octob...
In his session at DevOps Summit, Tapabrata Pal, Director of Enterprise Architecture at Capital One, will tell a story about how Capital One has embraced Agile and DevOps Security practices across the Enterprise – driven by Enterprise Architecture; bringing in Development, Operations and Information Security organizations together. Capital Ones DevOpsSec practice is based upon three "pillars" – Shift-Left, Automate Everything, Dashboard Everything. Within about three years, from 100% waterfall, C...
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, discussed the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports.
"We're bringing out a new application monitoring system to the DevOps space. It manages large enterprise applications that are distributed throughout a node in many enterprises and we manage them as one collective," explained Kevin Barnes, President of eCube Systems, in this SYS-CON.tv interview at DevOps at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
In 2014, Amazon announced a new form of compute called Lambda. We didn't know it at the time, but this represented a fundamental shift in what we expect from cloud computing. Now, all of the major cloud computing vendors want to take part in this disruptive technology. In his session at 20th Cloud Expo, John Jelinek IV, a web developer at Linux Academy, will discuss why major players like AWS, Microsoft Azure, IBM Bluemix, and Google Cloud Platform are all trying to sidestep VMs and containers...
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and containers together help companies achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of Dev...
SYS-CON Events announced today that Catchpoint, a leading digital experience intelligence company, has been named “Silver Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Catchpoint Systems is a leading Digital Performance Analytics company that provides unparalleled insight into your customer-critical services to help you consistently deliver an amazing customer experience. Designed for digital business, C...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
@DevOpsSummit at Cloud taking place June 6-8, 2017, at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developm...
"We formed Formation several years ago to really address the need for bring complete modernization and software-defined storage to the more classic private cloud marketplace," stated Mark Lewis, Chairman and CEO of Formation Data Systems, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Updating DevOps to the latest production data slows down your development cycle. Probably it is due to slow, inefficient conventional storage and associated copy data management practices. In his session at @DevOpsSummit at 20th Cloud Expo, Dhiraj Sehgal, in Product and Solution at Tintri, will talk about DevOps and cloud-focused storage to update hundreds of child VMs (different flavors) with updates from a master VM in minutes, saving hours or even days in each development cycle. He will also...
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
A look across the tech landscape at the disruptive technologies that are increasing in prominence and speculate as to which will be most impactful for communications – namely, AI and Cloud Computing. In his session at 20th Cloud Expo, Curtis Peterson, VP of Operations at RingCentral, will highlight the current challenges of these transformative technologies and share strategies for preparing your organization for these changes. This “view from the top” will outline the latest trends and developm...
Things are changing so quickly in IoT that it would take a wizard to predict which ecosystem will gain the most traction. In order for IoT to reach its potential, smart devices must be able to work together. Today, there are a slew of interoperability standards being promoted by big names to make this happen: HomeKit, Brillo and Alljoyn. In his session at @ThingsExpo, Adam Justice, vice president and general manager of Grid Connect, will review what happens when smart devices don’t work togethe...
When you focus on a journey from up-close, you look at your own technical and cultural history and how you changed it for the benefit of the customer. This was our starting point: too many integration issues, 13 SWP days and very long cycles. It was evident that in this fast-paced industry we could no longer afford this reality. We needed something that would take us beyond reducing the development lifecycles, CI and Agile methodologies. We made a fundamental difference, even changed our culture...