FDA recall D-1067-2020

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 for recall

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.

Key facts

Status

Terminated

Initiation date

2020-03-16

Report date

2020-04-01

Termination date

2021-10-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1067-2020