Why it was recalled
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Product description
SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147103
Lot numbers, UPCs & expiration codes
SKU 051220024 All lots labeled to contain methanol
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1571-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 14, 2020
- FDA report date
- Sep 9, 2020
- Quantity
- 9600 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SG24 LLC
Original FDA data
Every field from FDA enforcement report D-1571-2020, exactly as published.
Show all FDA fields
- City
- Bolingbroke
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 86270
- Address
- 8315 Rivoli Road
- Address (line 2)
- Ste A
- Code information
- SKU 051220024 All lots labeled to contain methanol
- Postal code
- 31004
- Report date
- Sep 9, 2020
- Product type
- Drugs
- Recall number
- D-1571-2020
- Classification
- Class I
- Recalling firm
- SG24 LLC
- Product quantity
- 9600 bottles
- Termination date
- Jun 5, 2023
- Reason for recall
- Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147103
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 14, 2020
- Initial firm notification
- Press Release
- Center classification date
- Sep 11, 2020