FDAMarch 16, 2020drug

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.)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

glaxosmithkline consumer healthcareglaxosmithklineglaxosmithkline consumer

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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.) — Recall Details · AllClear