PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: September 9, 2020 Initiated: August 14, 2020 #D-1573-2020

Product Description

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

Details

Recalling Firm
SG24 LLC
Units Affected
10,000 pens
Distribution
Nationwide
Location
Bolingbroke, GA

Frequently Asked Questions

What product was recalled?
Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147097. Recalled by SG24 LLC. Units affected: 10,000 pens.
Why was this product recalled?
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Which agency issued this recall?
This recall was issued by the FDA Drug on September 9, 2020. Severity: Critical. Recall number: D-1573-2020.