FDA recall D-0317-2024

Haleon US Holdings LLC · Class I · drug

Product

Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

Reason for recall

Microbial Contamination of Non-Sterile Products

Distribution

USA nationwide

Key facts

Status
Ongoing
Initiation date
2023-12-26
Report date
2024-01-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0317-2024