Class I · High risk
Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
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
- Recalling firm
- Sg24 LLC
- Origin
- GA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1574-2020 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Sg24 LLC
All 2020 recalls
Class I · High risk
SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk
SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Other chemical / undeclared recalls from 2020
All chemical / undeclared recalls
Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class I · High risk
TraZODONE Hydrochloride Tablets USP 100 mg
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
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