FDA recall D-1069-2020

Glaxosmithkline Consumer Healthcare Holdings · Class II · drug

Product

Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB

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-1069-2020