Class II · Moderate risk
Killz Germz Hand Sanitizer
Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
Genesis Hand Sanitizer Gel
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-04, UPC 7401037203427.
Affected NDC
74484-0002-04
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Genesis Partnership Company SA
- NDC code
- 74484-002-04
- Origin
- N/A, Guatemala
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0039-2021 · 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.
Other recalls by Genesis Partnership Company SA
All 2020 recalls
Class II · Moderate risk
Killz Germz Hand Sanitizer
Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
Class II · Moderate risk
Genesis Hand Sanitizer Gel
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Class II · Moderate risk
Panagel Hand Sanitizer
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Other cgmp deviation recalls from 2020
All cgmp deviation recalls
Class II · Moderate risk
Auryxia (ferric citrate)
CGMP Deviations
Class II · Moderate risk
Docetaxel Injection USP 160 mg/8mL
CGMP Deviations
Class II · Moderate risk
Imatinib Mesylate Tablets 400 mg
CGMP Deviations
Class II · Moderate risk
Imatinib Mesylate Tablets 100 mg
CGMP Deviations
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