CLASS II ONGOING Drug recall · Reported 20 Jan 2021 · FDA Enforcement Report
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing recalled
Gaza Proveedora De Servicios De Hospedaje Y Alimentacion is recalling Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, distributed in Texas. The recall was initiated on 1 Dec 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0229-2021
- FDA event ID
- 86898
- Recalling firm
- Gaza Proveedora De Servicios De Hospedaje Y Alimentacion, Tonala, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Dec 2020
- FDA classified
- 14 Jan 2021
- Reported
- 20 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 1 Dec 2020 | Recall initiated by company | |
| 14 Jan 2021 | Classified by FDA | +44 days |
| 20 Jan 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Product as listed by the FDA
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
Where it was distributed
TX
Questions about this recall
Is Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing recalled?
Yes. Gaza Proveedora De Servicios De Hospedaje Y Alimentacion recalled Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing on 1 Dec 2020. The recall is Class II and its status is Ongoing. Recall number D-0229-2021.
Why was it recalled?
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Which lots are affected?
All Lots
Where was it sold?
TX
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Gaza Proveedora De Servicios De Hospedaje Y Alimentacion
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zapien Productos Hand Sanitizer Gel Antibacterial, Made by GAZA S.A recalled | Gaza Proveedora De Servicios De Hospedaje Y Alimentacion | Manufacturing (CGMP) Deviations | TX |