Global Hand Sanitizer with moisturizer

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Does not meet monograph for denaturant.

The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.

What was recalled

Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01

Affected NDC 80253-0001-01

Compare with the code on your package — it is the most precise check available.

Drug: Alcohol

Recalling firm: Cascade Kelly Holdings LLC
NDC code: 80253-001-01
Origin: OR, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0697-2021 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.