# FDA recall D-0230-2021

> **GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION** · Class II · drug recall initiated 2020-12-01.

## 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.

## Distribution

TX

## Key facts

- **Recall number:** D-0230-2021
- **Recalling firm:** GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2020-12-01
- **Report date:** 2021-01-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tonala, N/A, Mexico

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0230-2021

## Citation

> AI Analytics. FDA recall D-0230-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0230-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*