One lot of Pediatrix Acetaminophen Oral Solution recalled in Canada

Excerpt

One lot of Pediatrix Acetaminophen Oral Solution (paracetamol oral solution for children; Lot MC0079; expiry date Aug 2025) is being recalled by Teva Canada due to the potential risk of overdose, reports Health Canada.The lot is being recalled after routine testing found a higher than acceptable amount of paracetamol in the solution (approximately 185mg per 5mL rather than the approved and labelled 160mg per 5mL), which could result in drug overdose in children.Signs and symptoms of paracetamol overdose include nausea, vomiting, lethargy, sweating, loss of appetite, and pain in the upper abdomen or stomach. Abdominal pain may be the first sign of liver damage, which may occur after 24 to 48 hours, and may result in liver failure or death.Pediatrix Acetaminophen Oral Solution is available without a prescription in Canada and is used to relieve mild to moderate pain and fever in children between two and 11 years of age.Health Canada is monitoring Teva's recall and its implementation of any necessary corrective and preventative actions. Parents or caregivers should stop using the affected product, and should call their local poison control centre or emergency healthcare services immediately if their child develops signs or symptoms of paracetamol overdose. They should return the product to their local pharmacy for proper disposal. …