Childrens Advil Suspension
FDA Recall NDC 0573-0171
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Childrens Advil (NDC 0573-0171). A significant event, classified as Class II, was initiated on Aug 23, 2018 by Haleon Us Holdings Llc. The reported reason for this action was: "Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
Aug 23, 2018
Sep 05, 2018
17,136 bottles
Recall Profile & Regulatory Data
Event ID
80876
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Global Supply
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Feb 11, 2021
Product Description
Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0
Batch or Lot Expiration Information
Lot# : R51129, Exp. 11/20
Affected Packages Involved in this Recall
0573-0174-30Product
0573-0171-30Product
0573-0171-03Product
0573-0171-32Product
0573-0170-30Product
0573-0170-01Product
0573-0170-32Product
0573-0290-30Product
0573-0290-01Product
0573-0207-30Product
0573-0232-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
