FDA recall D-1066-2020

Glaxosmithkline Consumer Healthcare Holdings · Class II · drug

Product

Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95

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-1066-2020