FDA recall D-1573-2020

SG24 LLC · Class I · drug

Product

Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147097

Reason for recall

Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2020-08-14
Report date
2020-09-09
Termination date
2023-06-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bolingbroke, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1573-2020