Drugmaker Teva Canada is recalling a batch of pain and fever relief medications in children because they contain too much acetaminophen and pose a risk of overdose.
The recall notice published by Health Canada targets Pediatrix oral acetaminophen solution with a concentration of 160 mg/5 ml on the packaging and an expiry date of August 2025.
The federal agency says routine testing of the product revealed an amount of acetaminophen above the acceptable limit in the lot affected by the recall.
Health Canada explains that bottles of the drug with lot number MC0079 contain approximately 185 mg of acetaminophen per 5 ml, rather than the approved and labeled level of 160 mg/5 ml.
“This situation could result in children receiving too much acetaminophen. Children are particularly at risk of experiencing the effects of an acetaminophen overdose due to their small size and developing bodies,” the agency warns.
She says signs of an acetaminophen overdose include nausea, vomiting, lethargy, sweating, loss of appetite and pain in the upper abdomen or stomach.
Pediatrix acetaminophen oral solution is available without a prescription and is intended for use in children ages 2 to 11 years.
Health Canada says that because the recall is limited in scope, it will have no impact on the general availability of children’s acetaminophen products across the country.