Herbal detox and laxative products Formule L1 and Detox Spring Fall recalled due to missing risk statements on label

Starting date:

February 27, 2014

Posting date:

February 27, 2014

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Labelling and Packaging

Audience:

General Public

Identification number:

RA-38149

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  Issue
• 
  Products affected
• 
  What you should do
• 
  Who is affected
• 
  Background
• 
  Report health or safety concerns
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing
• 
  Images

Issue

Health Canada is informing Canadians that Les Importations Herbasanté 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.

Products affected

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

What you 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 Herbasanté Inc. at 1-800-446-4242.

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.

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.

Report health or safety concerns

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.

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709

What Health Canada is doing

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

Images

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