FDA (Drugs) recall action 86270
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
SG24 LLC is recalling SkinGuard 24 All-Day Hand Sanitizer because it is an unapproved new drug containing methanol.
SG24 LLC is recalling Skin Guard 24 All-Day Hand Sanitizer pens because they are labeled to contain methanol, making them unapproved new drugs.
SG24 LLC is recalling Skin Guard 24 hand sanitizing towelettes because they contain unapproved methanol and lack FDA approval.
SG24 LLC is recalling SkinGuard 24 Hand Sanitizer because it is an unapproved new drug containing methanol.