Safety Report: Pediatrix Acetaminophen Oral Solution - recalled due to potential risk of overdose, Canada

Canada

Teva Canada Ltd. is recalling a single lot of its Pediatrix Acetaminophen Oral Solution for children due to an increased risk of overdose. The product was distributed nationwide in Canada. The product is available without a prescription and is used to relieve mild to moderate pain and fever in children from 2 to 11 years of age.

The recalled product is marketed under the brand name Pediatrix, and is an acetaminophen oral solution with a concentration of 160mg/5mL. The product is sold in a size/weight of 4 ounces, and the affected batch carries the number MC0079. The product associated UPC is 02027798, with a best before date of August 2025 and DIN 02027798.

The anomaly in the product concentration was discovered through routine testing procedures. It was found that a specific lot of the solution contained approximately 185mg/5mL of acetaminophen, as opposed to the approved and labelled 160mg/5mL. Consequently, if the said lot is used, it could potentially induce an overdose of acetaminophen.

Acetaminophen overdose may cause symptoms such as nausea, vomiting, lethargy, sweating, and loss of appetite. It is important to be aware of this risk as timely intervention is crucial to avoid further complications like liver damage.

If your kid is harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

Source: recalls-rappels.canada.ca/en/alert-recall/pediatrix-acetaminophen-oral-solution-children-one-lot-recalled-due-potential-risk