August 2018 FDA Recall Childrens Advil by Pfizer Global Supply
D-1169-2018 - Labeling Error
This Class II drug recall was voluntarily initiated by Pfizer Global Supply on August 23, 2018 for the product Childrens Advil. The FDA reported the reason for recall as labeling error. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1169-2018
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
08-23-2018
09-05-2018
17,136 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Global Supply
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
02-11-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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 3-0573-0207-30-0
Batch or Lot Expiration Information
Lot# : R51129, Exp. 11/20
