Class II · Moderate risk
Zapien Productos Hand Sanitizer Gel Antibacterial
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing
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
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5, NDC 76540-100-02
Affected NDC
76540-0100-02
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Gaza Proveedora De Servicios De Hospedaje Y Alimentacion
- NDC code
- 76540-100-02
- Origin
- N/A, Mexico
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0229-2021 · 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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