Health Canada recalls popular over-the-counter kids' medicine due to overdose risk
Health Canada has recalled a popular pain medicine meant for children after it was found to potentially lead to an overdose.
Teva Canada Ltd.’s Pediatrix Acetaminophen Oral Solution can be bought over the counter and is used to relieve mild to moderate pain and fever in kids aged between two and 11.
The recall was issued on Wednesday after the company routinely tested one lot of the medication.
Ordinarily, 5 ml of the solution should have 160 mg of acetaminophen, a common pain reliever also used to reduce fever. The test showed that the affected lot had approximately 185 mg of acetaminophen per 5 ml.
“This could lead to children receiving too much acetaminophen. Children may be especially at risk of the effects of acetaminophen overdose, given their small size and developing bodies,” wrote the health agency.
Here’s what the recalled medicine looks like:
Health Canada
The affected products are in lot number MC0079, which can be found next to the expiry date (August 2025 for this lot). The Drug Identification Number (DIN) is 02027798.
If you have the product in your medicine cabinet, stop using it immediately and return it to your local pharmacy for proper disposal. If you’ve already given it to your child, watch them for acetaminophen overdose symptoms.
These include vomiting, sweating, nausea, lethargy, and pain in the stomach or upper part of the abdomen.
Health Canada shared that the latter symptom may be the first sign of liver damage and may not become apparent for 24 to 48 hours. Damage to the organ can result in its failure and even death in severe cases.
If you spot any signs of an overdose, call your local poison control centre or emergency health care services immediately. You should also report the incident to Health Canada by using this form.
Teva Canada can answer questions about the recall by phone at 1-800-268-4129 or by email at [email protected].
Health Canada is currently monitoring the situation and will inform the public if it identifies new health risks related to the medication.
Since the recall has a limited scope, Canadians don’t have to worry about it affecting the general availability of acetaminophen products for kids.
Keep an eye on the latest Health Canada recalls here.
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