FDA recall D-0563-2023

Product

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.

Reason for recall

CGMP deviation: product outside labeled storage temperature requirements.

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2023-03-31

Report date

2023-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chesapeake, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0563-2023