Drug 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
D-1169-2018
Product summary
- Event
- Event 80876
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,136 bottles
- Official record key
drug-enforcement:D-1169-2018
Official wording
Reason: Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
Code information: Lot #: R51129, Exp. 11/20
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Labeling or packaging
Labeling Error