D-1573-2020 Class I Terminated
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