FDAClass IISeptember 5, 2018

Children s Advil Suspension Ibuprofen Oral Suspension recall: Labeling Error

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…

Why was Children s Advil Suspension Ibuprofen Oral Suspension recalled?

Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: R51129, Exp. 11/20

Product
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…
Recalling firm
Pfizer Global Supply
Quantity
17,136 bottles
Distribution
Nationwide within the United States
Recall date
September 5, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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