Due to a dosing error on the label, a recall has been issued for some “Bubble Gum” flavored children’s Advil bottles, which may result in a risk of overdose and potentially life-threatening injuries for children.
The FDA announced the Children’s Bubble Gum flavored Advil recall on August 27, after concluding the dosage recommendations are marked in a different measurement than the dosage cup provided, which may result in confusion and overdosing errors.
The action was taken after the manufacturer, Pfizer Inc., received several consumer complaints about problems with the dosage cup provided with the medication, which is marked in teaspoons, even though the label instructions are described in milliliters. This could result in doses of the Advil being administered to children that are higher than what is safe.
Pfizer initiated an investigation after receiving the complaints and determined the mismatched dosing instructions pose a risk of overdosing, and initiated a recall.
Children’s Advil is specially formulated and is required to have dosing instructions based on a child’s age and weight. The over-the-counter medication is used to temporarily reduce fevers, relieve minor aches and pains due to the common cold, flu, and sore throat and relieve headaches and toothaches.
Children who are given too much Advil can run the risk of overdose which is known to cause nausea, vomiting, headache, drowsiness, blurred vision and dizziness. In severe cases of children’s Advil overdoses, symptoms of sudden fainting, hallucination, muscle tremors, slow irregular heartbeat and bluish lips or skin could occur.
The recall includes Children’s Advil Suspension Bubble Gum Flavored 4 FL OZ bottles that are marked with NDC number 0573-0207-30, Lot number R51129, UPC number 3-0573-0207-30-0 and have an expiration date of November, 2020 printed in the MM/YY format.
The recalled children’s Advil was manufactured by Pfizer Inc., of New York City, New York where it was distributed nationwide to wholesalers, distributors and retailers in the United States from May 2018 through June 2018.
Pfizer has begun notifying wholesalers, distributors and retailers to check for any remaining inventory in stock or on store shelves and immediately quarantine the products and contact Stericycle at 1-800-805-3093 to arrange a pickup. Consumers should stop using the recalled Advil products immediately and either return them to their place of purchase or contact Pfizer Consumer Healthcare Information Line at 1-800-882-3845 for further information.