Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing — Class II drug recall D-0229-2021
Ongoing recall by GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION, reported 2021-01-20, distributed in TX. cGMP deviations: Product made at the same facility where product tested was sub-potent.
| Recall number | D-0229-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION, Tonala, N/A, Mexico |
| Recall initiated | 2020-12-01 |
| Classified | 2021-01-14 |
| Reported by FDA | 2021-01-20 |
| Distributed | TX |
| Quantity | 26,000 liters |
| Reason classes | potency, cgmp |
| UPC / GTIN / UDI-DI | 00864972000495 |
| NDC | 76540-0100-02 |
Product
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
Reason for recall
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0229-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.