Drug recall
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by…
FDA recall event 86898 · Class II · GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
Key facts
| Event ID | 86898 |
|---|---|
| Recall numbers | D-0229-2021, D-0230-2021 |
| Recalling firm | GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION |
| Product type | Drugs |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | cGMP deviations: Product made at the same facility where product tested was sub-potent. |
| Initiation date | Dec 1, 2020 |
| Report date | Jan 20, 2021 |
| City | Tonala |
| Country | Mexico |
| FEI number | 3016808324 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: