Drug product
Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147097
D-1573-2020
Product summary
- Firm
- SG24 LLC
- Event
- Event 86270
- Status
- Terminated
- Classification
- Class I
- Quantity
- 10,000 pens
- Official record key
drug-enforcement:D-1573-2020
Official wording
Reason: Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Code information: SKU 051210048 All lots labeled to contain methanol
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
contain 0.56% methanol