Recall: D-1067-2020

Class II - Potentially Harmful

Class IIClassification

2020-03-16Initiated

TerminatedStatus

Glaxosmithkline Consumer HealtFirm

Product

Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)

Reason

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Distribution

Product was distributed throughout the United States, including Puerto Rico.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.