FDA recall D-0565-2023

Family Dollar Stores, Llc. · Class II · drug

Product

Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets 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-0565-2023