FDA recall D-1571-2020

SG24 LLC · Class I · drug

Product

SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147103

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-1571-2020