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

OTTAWA, Nov. 14, 2018 /CNW/ -

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.

Biomedic Acetaminophen (160 mg/5 mL) children's syrup, strawberry flavour (lot B0504-A) (CNW Group/Health Canada)

Option+ Acetaminophen (160 mg/5 mL) children's syrup, strawberry flavour (lot B0504-C) (CNW Group/Health Canada)

Laboratoires Trianon Inc. Acetaminophen (160 mg/5 mL) children's syrup, strawberry flavour (lot B0504-E) (CNW Group/Health Canada)

Laboratoires Trianon Inc. Acetaminophen (160 mg/5 mL) children's syrup, strawberry flavour (lot B0504-B) (CNW Group/Health Canada)

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	Expiry	Units Distributed
Biomedic Acetaminophen (160 mg/5 mL) children's syrup, strawberry flavour	Laboratoire Riva Inc.	02226871	B0504-A	21-MA	3,360
Option+ Acetaminophen oral solution USP (160 mg/5 mL) children's syrup, strawberry flavour	Laboratoire Riva Inc.	02226871	B0504-C	2021-MA	2,364
Laboratoires Trianon Inc. Acetaminophen Oral solution USP (160 mg/5 mL) children's syrup, strawberry flavour	Laboratoires Trianon Inc.	01958836	B0504-B	21-MA	998
			B0504-E	2021-MA	2,264

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 [email protected], 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.

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SOURCE Health Canada

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries:[phone], 1-866 225-0709