Glaxosmithkline Consumer Healthcare Holdings recalls Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC…

Recall date

March 16, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1067-2020

FDA classification

Class II

Brand / firm

Glaxosmithkline Consumer Healthcare Holdings

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.)