FDA recall record

SG24 Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette recall — FDA D-1574-2020

Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug

Class Iclassification
D-1574-2020official record ID
Sep 9, 2020report date

Recall record at a glance

Official recordD-1574-2020
CategoryDrug Recalls
ClassificationClass I
FDA record statusTerminated
Recalling firmSG24 LLC
Report dateSep 9, 2020
Recall initiation dateAug 14, 2020
Quantity122,500 individual wipe packets
LocationBolingbroke, GA, United States

Official product description

Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packaged in 2.5 x 3.75 packets, Dist by: SG24 LLC, Bolingbroke, GA 31004

Why the product was recalled

Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug

Distribution information

Nationwide

How to read the classification

FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Press Release.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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