Skin Guard 24 Hand Sanitizer Recalled for Unapproved Methanol Content
SG24 LLC is recalling Skin Guard 24 All-Day Hand Sanitizer pens because they are labeled to contain methanol, making them unapproved new drugs.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
SG24 LLC is recalling 10,000 units of Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen. The product is distributed nationwide and is identified by SKU 051210048 and UPC 793573147097. All lots are labeled to contain 0.56% methanol.
The recall was initiated because the product was marketed without an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The presence of methanol in the labeling renders the product an unapproved new drug under FDA regulations.
Consumers who possess this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147097
- Manufacturer
- SG24 LLC
- Category
- Drug — Hand Sanitizer
- Hazard
- Affected units
- 10,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- SKU 051210048 All lots labeled to contain methanol
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by SG24 LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · SG24 LLC
See all →- CriticalFDA Recalls Skin Guard 24 Hand Sanitizing Towelettes for Unapproved Methanol
FDA (Drugs) · 2020-09-09
- SevereSkinGuard 24 Hand Sanitizer Recalled for Unapproved Methanol Content
FDA (Drugs) · 2020-09-09
- SevereSkinGuard 24 Hand Sanitizer Recalled for Unapproved Methanol Content
FDA (Drugs) · 2020-09-09
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