Children’s pain and fever medicine recalled due to risk of overdose

Health Canada is recalling one lot of children’s pain and fever medication from manufacturer Teva Canada Ltd. due to a risk of possible overdose.

The medication is sold over the counter without a prescription for children between the ages of two and 11-years-old.

A notice issued by Health Canada says that routine product testing found a higher than acceptable amount of acetaminophen in the affected lot of Pediatrix Acetaminophen Oral Solution.

The agency says that bottles with the number MC0079 and an expiry date of August 2025 contain approximately 185 mg of acetaminophen per 5 ml, compared to the approved and labelled 160 mg per 5 ml.

#Recall: Pediatrix Acetaminophen Oral Solution for children. One lot is being recalled due to possible risk of acetaminophen overdose, which may pose serious health risks: https://t.co/5p5uGMTpce pic.twitter.com/P0qYqZbdhI

— Health Canada and PHAC (@GovCanHealth) January 17, 2024

Canadians are advised to stop use of the affected lot of medications, return them to their local pharmacy and contact Health Canada should any side effects be experienced.

Products containing acetaminophen, including Tylenol, are used commonly for the treatment of fever and mild to moderate pain.

READ MORE: Respiratory-related ER visits surge at McMaster Children’s Hospital

According to Health Canada, this could result in children receiving an excess of acetaminophen that could lead to overdose. Signs of such an incident in children include nausea, vomiting, lethargy, seating, loss of appetite and pain in the upper part of the abdomen or stomach.

In the most severe cases, it can lead to liver damage or failure and in extreme cases, death.

The recall comes as hospitals warn of an uptick in illnesses among children this cold and flu season. Doctors at McMaster Children’s Hospital reported a surge in visits to the emergency room for respiratory-related illnesses back in November.

At that time, emergency physician Dr. April Kam said the hospital had been seeing a steady increase in visits for symptoms associated with the flu, RSV and COVID-19. She said that increase came earlier than in previous years.

Health Canada has advised the recall is limited in scope, with only one lot being affected, and says it will not have an impact on the general availability of the products country-wide.

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