Nov 20, 2018   SOURCE: PR NewsWire

UPDATE - Advisory - Several children's strawberry-flavoured acetaminophen syrups recalled because of defective child-resistant safety caps on the bottles

OTTAWA, Nov. 20, 2018 /CNW/ - The recall has been expanded to include all lots of children's strawberry-flavoured acetaminophen syrups labeled as Biomedic, Option+, or Laboratoires Trianon Inc. because of defective child-resistant safety caps. The table below, which previously listed only specific lots, now shows that all lots are being recalled.

Original Advisory - November 14, 2018

Issue
Laboratoire Riva Inc. and Laboratoires Trianon Inc. are voluntarily recalling several over-the-counter children's strawberry-flavoured acetaminophen syrups labeled as Biomedic, Option+, or Laboratoires Trianon Inc. The products, which are used for pain and fever relief, are being recalled because the child-resistant safety cap may be defective.

A defective cap could allow a child to accidentally ingest the product, which would pose a significant health concern. Accidental ingestion can result in acetaminophen overdose and serious health consequences, including liver damage in extreme cases. 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.

This issue is related to product packaging and not the safety or effectiveness of the drug in the bottles. The products were distributed at major pharmacies across Canada.

Who is affected

    --  Consumers who have bought the affected products listed in the table
        below

Affected products


                        Description 
            
              Company 
     
      DIN              Lot 
            
      Units
                                                                                          Distributed

    ---

             Biomedic Acetaminophen 
            Laboratoire            02226871 All lots                      33,595
             (160 mg/5 mL)
              children's            Riva Inc.
    syrup, strawberry
     flavour

    ---

             Option+ Acetaminophen  
            Laboratoire            02226871 All lots                      33,604
    oral solution USP               Riva Inc.
             (160 mg/5 mL)
              children's
    syrup, strawberry
     flavour

    ---

             Laboratoires Trianon
              Inc.                  
            Laboratoires           01958836 All lots                      49,423
    Acetaminophen Oral              Trianon Inc.
    solution USP
             (160 mg/5 mL)
              children's
    syrup, strawberry
     flavour

    ---

What consumers should do

    --  Return affected product to the place of purchase for a refund.
    --  Call your local poison control centre immediately if you think your
        child may have taken too much acetaminophen. Consult your health care
        professional if your child has used these products and has health
        concerns.
    --  Contact Urszula Wiatrowska, Pharmacovigilance Specialist at Laboratoire
        Riva and Laboratoires Trianon Inc., if you have questions about the
        recall. Email uwiatrowska@labriva.com, or call toll-free at
        1-800-363-7988, extension 236.
    --  Store medications out of reach and sight of children.
    --  Report any health product-related adverse reactions or complaints to
        Health Canada.

What Health Canada is doing
Health Canada is monitoring the recalls. Should additional safety concerns be identified related to this issue, Health Canada will take appropriate action and inform Canadians as necessary.

Stay connected with Health Canada and receive the latest advisories and product recalls.

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SOURCE Health Canada