“Compliments Muscle and Back Pain Relief Regular Strength”: Labelling Error May Pose Serious Risks to Children

Starting date:
December 29, 2011
Posting date:
December 29, 2011
Type of communication:
Advisory
Subcategory:
Drugs, Affects children, pregnant or breast feeding women, Affects children, pregnant or breast feeding women, Specialized Products
Source of recall:
Health Canada
Issue:
Labelling and Packaging, Product Safety
Audience:
General Public
Identification number:
RA-110004830

Issue

Health Canada is advising Canadians that Vita Health's product, "Compliments Muscle and Back Pain Relief Regular Strength" contains a significant labelling error in the French dosing directions that may pose serious risks to children (less than 12 years of age), if taken by them. According to the product label, this product is for adult use only and should not be administered to children less than 12 years of age. This product is advertised as a muscle relaxant and painkiller.

Health Canada is advising Canadians that Vita Health's product, "Compliments Muscle and Back Pain Relief Regular Strength" contains a significant labelling error in the French dosing directions that may pose serious risks to children (less than 12 years of age), if taken by them. According to the product label, this product is for adult use only and should not be administered to children less than 12 years of age. This product is advertised as a muscle relaxant and painkiller.

The current incorrect French label under "Posologie" states "Adultes et enfants de 2 ans et plus" whereas it should read "Adultes et enfants de 12 ans et plus". However, the statement "Ne pas administrer aux enfants âgés de moins de 12 ans" appears later on in the same section (See photos below). Health Canada would like to remind consumers that the English dosing directions contain no errors and the label correctly states for "Adults and Children 12 years and older."

What you should do

  • Consult your healthcare practitioner if your child (less than 12 years of age) has used this product.
  • Contact Vita Health Customer Service at 1-800-665-8820 concerning the recall of this product and how to obtain a refund.
  • Report any adverse reaction potentially related to this product to Health Canada (see below).

Who is affected

Canadians who have purchased "Compliments Muscle and Back Pain Relief Regular Strength" for use by their children who are less than 12 years of age.

Background

"Compliments Muscle and Back Pain Relief Regular Strength" is advertised as a muscle relaxant and painkiller for the relief of minor pain associated with muscle spasm such as back pain, tense neck muscles and strains and sprains. Each caplet contains 325 mg of acetaminophen and 400 mg of methocarbamol. The maximum recommended daily dose for adults and children 12 years and older is eight caplets.

Ingestion by children less than 12 years of age can result in acetaminophen overdose and may cause serious health consequences including liver damage. Early signs of overdose include nausea, vomiting lethargy and sweating. Liver damage may result in liver failure or death. Abdominal pain may be the first sign of liver damage and may not be apparent for 24 to 48 hours.

Report health or safety concerns

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

Facsimile: 1-866-678-6789
Email: CanadaVigilance@hc-sc.gc.ca
Internet: MedEffect Canada
Mail: Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701C
K1A 0K9
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

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Vita Health is recalling five affected lots of the product (0K078B27ZI, 0K078B29VL, IA100B2AQH, 1H106B2GVP and 1H106B2HJJ) in the 18 tablet package from the Canadian market. Canadians can be confident that Health Canada is monitoring the voluntary recall by Vita Health. Should additional information be identified, Health Canada will take appropriate action and inform Canadians.

Images

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