Recalls / Class II
Class IID-1169-2018
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
- Brand name
- Childrens Advil
- Generic name
- Ibuprofen
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDCs
- 0573-0170, 0573-0174, 0573-0171, 0573-0290, 0573-0207, 0573-0232
- FDA application
- NDA020589
- Affected lot / code info
- Lot #: R51129, Exp. 11/20
Why it was recalled
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
Recalling firm
- Firm
- Pfizer Global Supply
- Manufacturer
- Haleon US Holdings LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- One Burtt Road, N/A, Andover, Massachusetts 01810
Distribution
- Quantity
- 17,136 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2018-08-23
- FDA classified
- 2018-08-30
- Posted by FDA
- 2018-09-05
- Terminated
- 2021-02-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1169-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.