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 ND
Recalled April 1, 2020 · FDA recall D-1067-2020 · Glaxosmithkline Consumer Healthcare Holdings
Hazard
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. · FDA Class II
Units
151,056 bottles
Sold at
Product was distributed throughout the United States, including Puerto Rico.
Description
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
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.)
Manufacturer(s)
Glaxosmithkline Consumer Healthcare Holdings
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →