Public advisory

Robikids and Solmux are unauthorized children’s syrups for thinning mucus and may pose serious health risks

Brand(s)
Last updated

Summary

Product
Unauthorized health products labelled to contain a prescription drug
Issue
Health products - Product safety
What to do

Do not use these products. Return them to your local pharmacy for proper disposal. Consult a health care professional if you or your child have used either of these products and have health concerns. Prescription drugs can only be legally sold with a prescription. Buy your prescription drugs from licensed pharmacies only.

Affected products

Product Prescription drug on the label
Robikids Carbocisteine Mucolytic
120 mL (250 mg / 5 mL)
Labelled to contain carbocisteine
Solmux Carbocisteine Mucolytic Pediatric Syrup
120 mL (200 mg / 5 mL)
Labelled to contain carbocisteine

Issue

Health Canada is warning parents and caregivers about two unauthorized children's syrups for thinning mucus, Robikids and Solmux, seized from Kamshoppe, which advertised the products on Facebook. Both products are labelled to contain carbocisteine, a prescription drug that may pose serious health risks such as nausea, diarrhea, allergic reactions (e.g., anaphylaxis) and gastrointestinal bleeding. Should Health Canada identify other distributors or retailers of these unauthorized health products, it will take action and inform the public as appropriate.

Selling unauthorized health products in Canada is illegal. Unauthorized health products have not been approved by Health Canada, which means that they have not been assessed for safety, efficacy and quality and may pose a range of serious health risks. For example, they could contain high-risk ingredients, such as prescription drugs, additives or contaminants that may or may not be listed on the label. These ingredients could interact with other medications and foods. In addition, these products may not actually contain the active ingredients that consumers would expect them to contain to help maintain and improve their health.

Prescription drugs should only be used under the advice and supervision of a health care professional because they are used to treat specific conditions and may cause serious side effects.

What you should do

  • Do not use these products. Return the product to your local pharmacy for proper disposal.
  • Consult a health care professional if you or your child have used either of these products and have health concerns.
  • Buy your prescription drugs only from licensed pharmacies.
  • Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have been authorized for sale by searching Health Canada's Drug Product Database and Licensed Natural Health Product Database.
  • Report any health product-related side effects or complaints to Health Canada.

Additional information

Background

Carbocisteine is a prescription drug that is not approved for use in Canada. It is used in other countries to treat conditions associated with too much mucus in the respiratory tract. Side effects include diarrhea, nausea and heartburn. Serious allergic (e.g., anaphylactic) and skin reactions have been reported with its use. Carbocisteine can disrupt the lining of the stomach and can cause gastrointestinal bleeding in the elderly, those with a history of peptic ulcers, or patients taking medications known to cause gastrointestinal bleeds such as acetylsalicylic acid (ASA) or non-steroidal anti-inflammatory drugs (NSAIDs). The use of carbocisteine by pregnant people is not recommended.

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products - Drugs
Companies
Published by
Health Canada
Audience
General public
Identification number
RA-73331
Media and public enquiries

Health Canada
613-957-2983
media@hc-sc.gc.ca

Public Enquiries:
613-957-2991
1-866-225-0709
info@hc-sc.gc.ca