Health Canada is pulling a pain and fever medicine for children off the shelves because of the “potential risk of overdose.”
The agency issued a recall alert Wednesday for one lot of Pediatrix Acetaminophen Oral Solution sold by Teva Canada Ltd.
The medicine is sold over the counter without a prescription and it’s for children aged two to 11 years.
The recall was prompted after the company found in routine testing a higher than acceptable amount of acetaminophen in the affected lot. Instead of the approved and labelled amount of 160 mg of acetaminophen per 5 mL, the product had approximately 185 mg per 5 mL.
“This could lead to children receiving too much acetaminophen,” Health Canada said.
“Children may be especially at risk of the effects of acetaminophen overdose given their small size and developing bodies.”
The health agency is advising Canadians to stop using the affected lot of oral medicines which have the expiry date August 2025 and return them to the local pharmacy.
Any side effects should be reported to Health Canada.
Acetaminophen overdose can cause nausea, vomiting, lethargy, sweating, loss of appetite and pain in the upper part of the abdomen or stomach, according to Health Canada.
In the most severe cases, this can also lead to liver damage or failure and even death.
The lot number to watch for on the bottle is MC0079, commonly written next to the expiration date.
The recall comes as Canada is in the midst of the respiratory virus season.
Acetaminophen products, like Tylenol and Panadol, are used to treat fever and mild to moderate pain.
There was a shortage of pain medication for infants and children in late 2022 and early 2023 due to what Health Canada said was an “unprecedented high demand that began in the summer of 2022.”
Ahead of this winter, industry experts told Global News in November that the problem has been resolved and the risk of shortages is “minimal.”
Health Canada said that since this latest recall is limited in scope — only one lot if affected — it will not have any impact on the general availability of children’s acetaminophen products.
— with a file from Global News’ Naomi Barghiel