D-1573-2020 Class I Terminated

Recalled by SG24 LLC — Bolingbroke, GA

Recall Details

Product Type
Drugs
Report Date
September 9, 2020
Initiation Date
August 14, 2020
Termination Date
June 5, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,000 pens

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

Distribution Pattern

Nationwide

Code Information

SKU 051210048 All lots labeled to contain methanol