FDA Recall D-1573-2020
SG24 LLC · Bolingbroke, GA
Class I — life-threatening Terminated 1025 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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
Recall record
- Recall number
D-1573-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2020-08-14
- Classified by FDA Center
- 2020-09-11
- FDA published
- 2020-09-09
- Terminated
- 2023-06-05
- Recalling firm
- SG24 LLC
- Firm location
- Bolingbroke, GA