Class II · Moderate risk
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Zapien Productos Hand Sanitizer Gel Antibacterial
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations: Product made at the same facility where product tested was sub-potent.
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
Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, Mexico, UPC: 7 501700 623504, NDC numbers: 76938-001-01, 76938-001-02, 76938-001-03.
Affected NDCs
76938-0001-01
76938-0001-02
76938-0001-03
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Gaza Proveedora De Servicios De Hospedaje Y Alimentacion
- Origin
- N/A, Mexico
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0230-2021 · 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.
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