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 Number: D-1067-2020

Firm: Glaxosmithkline Consumer Healthcare Holdings

Classification: Class II

Status: Terminated

Report Date: 20200401

Initiation Date: 20200316

Termination Date: 20211028

Reason for Recall

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

Product Description

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.)