Recall : Pfizer Children’s Advil Suspension Bubble Gum Flavored 4 Fl Oz Bottle – FDA

by Kim Boateng Posted on August 29th, 2018

Silver Spring, Maryland, USA: The U.S. Food and Drug Administration, FDA, said 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 that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).

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

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.

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.

Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle Lot and Packaging Information

NDC Lot
Number
Expiration Date SKU UPC Configuration/Count
0573-0207-30 R51129 11/20 F005730207300 3-0573-0207-30-0 4 FL OZ (120 ml)
Bottle
36 bottles/case

Pfizer, Inc. places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.

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 use and 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. For instructions on returning product or additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

If consumers have questions regarding this recall or to report an adverse event, please contact the Pfizer Consumer Healthcare Information Line at 1-800-88-Advil (1-800-882-3845). Their hours of operation are Mon-Fri, 9am-5pm EST.

Consumers should contact their 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 either by phone, on line, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or the company.

FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Author

Kim Boateng

Kim Boateng

Staff Writer
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