Acetaminophen Oral Medicine Recall [Canada]


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Canada/Ottawa: Acetaminophen Oral Drop Recall [Canada]Laboratoire Riva Inc. and Laboratoires Trianon Inc., related companies based in Blainville, Quebec, recalls an estimated 50,000 units of over-the-counter strawberry-flavoured Biomedic, Option+, Personnelle, Selection, or Laboratoires Trianon Inc branded Acetaminophen Oral Drops for infants due to suspected failure to meet Canadian regulations for child-resistant packaging injury hazard and consequential risks of overdose, nausea, liver injury, and death, all serious health and safety hazards.

HCSC: http://ht.ly/twhA30mXqJF

Direct link: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/68574a-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports the following Acetaminophen drug formulations are subject to this recall:

  • Laboratoire Riva Inc. Biomedic branded Acetaminophen (80 mg/mL) Infant Oral Drops, strawberry flavour, sold in 24 mL bottles with a DIN of 02226898
  • Laboratoire Riva Inc. Option+ branded Acetaminophen Infant Oral Drops USP (80 mg/mL), strawberry flavour sold in 24 mL bottles with a DIN of 02226898
  • Laboratoire Riva Inc. Personnelle branded Acetaminophen Infant Oral Drops USP (80 mg/mL), strawberry flavour, sold in 24 mL bottles with a DIN of 02226898
  • Laboratoire Riva Inc. Selection branded Acetaminophen Infant Oral Drops USP (80 mg/mL), strawberry flavour, sold in 24 mL bottles with a DIN of 02226898
  • Laboratoires Trianon Inc. branded Acetaminophen Oral Solution USP (80 mg/mL) Children’s Syrup, strawberry flavour, sold in 24 mL bottle with a DIN of 01905864

Please note: batch/lots, expiry dates and estimated units sold of each formulation can be found on the Web site above.

Please consult the photograph above for details of the product’s packaging, design and retail presentation. Additional images of the recalled Acetaminophen drug formulations can be found on the Web site above.

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to Health Canada, Laboratoire Riva and Laboratoires Trianon have recalled five (5) over-the-counter strawberry-flavoured Biomedic, Option+, Personnelle, Selection and Laboratoires Trianon Inc. branded Acetaminophen Oral Drops for infants.

The recalled products are packaged in 24 mL bottles and are used for pain and fever relief. They are being recalled because the child-resistant safety cap may be defective. This recall is in addition to previous recalls of children’s acetaminophen syrups for the same issue.

A defective cap could allow a child to accidentally ingest the Acetaminophen product, posing a significant health concern. Accidental ingestion can result in Acetaminophen overdose and serious health consequences, including liver damage. Early signs of overdose include nausea, vomiting, lethargy and sweating. Liver damage may result in liver failure or, in the most severe cases, death. Abdominal pain may be the first sign of liver damage and may not be apparent for 24 to 48 hours.

If you believe you have purchased or have in your possession any of the recalled Acetaminophen formulation, please do not use them nor administer the medication to your child. Instead, kindly return the product to the store where you purchased it for a full refund.

Please note: disposal of this product and other drugs must be in accordance with local municipal hazardous waste requirements to protect your personal safety, the local drinking water supply and the ecosystem. Return unused portions to your local pharmacy for proper disposal.

If you have any questions about this recall notification, please contact Urszula Wiatrowska, Pharmacovigilance Specialist at Laboratoire Riva and Laboratoires Trianon Inc. toll-free at 1-800-363-7988, extension 236, from 8:00 AM to 5:00 PM, Eastern Standard Time, Monday to Friday. Alternatively, you can e-mail the company at uwiatrowska@labriva.com.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to handle poisonings.

Please note: the Canada Consumer Product Safety Act prohibits recalled products from being redistributed, sold or even given away in Canada.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous Acetaminophen, please search for “Acetaminophen” or more generically, “pain” using the Search Box at the top of this page.

==> To see all recalls and notifications relating to Drugs and/or Medications, including over-the-counter (“OTC”) preparations, please search for “drug” using the Search Box at the top of this page.

==> To see all recalls and notifications relating to Infants and Children, please search for “children” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Laboratoire Riva Inc., please search for “Riva” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Laboratoires Trianon Inc., please search for “Trianon Inc.” using the Search Box at the top of this page.

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More information about this recall:
HCSC ID number: RA-68574
Recalls Direct RIN: 10927-2018
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe product you purchased in Canada [external: new window opens]:
==> http://www.hc-sc.gc.ca/cps-spc/advisories-avis/incident/index-eng.php
Search for a recalled product on the Health Canada Web site [external: new window opens]:
==> http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

We welcome your feedback:
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E. & O. E.

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