FDA recall D-0566-2023

Family Dollar Stores, Llc. · Class II · drug

Product

Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.

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-0566-2023