Nationwide Recall Issued For Children's Bubble Gum Flavored Advil Suspension

The dosage cap can possibly lead to unintentional overdose

Nationwide Recall Issued For Children's Bubble Gum Flavored Advil Suspension
Image: Pixabay
August 29, 2018

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children's Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints regarding the dosage cap. Consumers have reported to the company that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).

Potential Consequences

The use of the product with an unmatched dosage cup marked in teaspoons rather than milliliters has a chance of being associated with potential overdose.

Symptoms of Overdose

The most common symptoms associated with ibuprofen overdose include nausea, vomiting, headache, drowsiness, blurred vision and dizziness.

Product Uses

Children's Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle temporarily reduces fever, relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches.

Nationwide Distribution

Children's Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle, NDC 0573-0207-30, lot R51129 was distributed nationwide to wholesalers, distributors and retailers in the United States from May 2018 through June 2018.

Stop Use, Return The Product

Pfizer, Inc. has notified wholesalers, distributors and retailers to arrange for return of any recalled product. Wholesalers, distributors and retailers with an existing inventory of the lot being recalled should stop distribution and quarantine the product immediately. Wholesalers, distributors and retailers that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them.

Consumers should contact a healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program.

For instructions on returning product or additional assistance, call Stericycle at (800) 805-3093. If consumers have questions regarding this recall or to report an adverse event, please contact the Pfizer Consumer Healthcare Information Line at (800) 882-3845.