D-1572-2020 Class I Terminated
FDA drug recall D-1572-2020 was initiated by SG24 LLC on August 14, 2020 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug The recall status is terminated (terminated June 5, 2023). Affected quantity: 9600 bottles.
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
- 9600 bottles
Product Description
SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147125
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 051230024 All lots labeled to contain methanol