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CHCC: Pfizer issues recall of children’s Advil
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Posted on Sep 10 2018
Pfizer Inc. is voluntarily recalling of one lot of its children’s fever or pain reducer medicine.
According to a statement from the Commonwealth Healthcare Center, Pfizer Consumer Healthcare, a division of Pfizer Inc. announced that it is recalling one lot of Children’s Advil Suspension Bubble Gum Flavored 4 fl oz bottle due to several customer complaints on dosage cup markings being inconsistent with label instructions, which could cause possible overdosage.
The dosage cup is marked in teaspoon while the instructions on the label are described in milliliters.
“Pfizer concluded that the use of the product with an unmatched dosage marked in teaspoons rather than milliliters has a chance of being associated with potential overdose,” the CHCC statement noted.
Overdose 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, NDC 0573-0207-30, lot R51129 was distributed nationwide to wholesalers, distributors, and retailers in the U.S. from May 2018 through June 2018.
“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,” the announcement stated.
“Adverse reactions or quality problems associated with the use of this product may be reported to the U.S. Food and Drug Administration’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail, or by fax,” the statement continued.
The reporting program may be accessed online at www.fda.gov/medwatch/report/htm or by dialing 1-800-332-1088 to request a reporting form to be mailed out to the address indicated on the form or submitting it by fax to 1-800-331-0178.
