Zapien Productos Hand Sanitizer Gel Antibacterial — Class II drug recall D-0230-2021
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-0230-2021 |
|---|---|
| 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 | 43,875 liters |
| Reason classes | potency, cgmp |
| NDC | 76938-0001-01, 76938-0001-02, 76938-0001-03 |
Product
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.
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-0230-2021. 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.