Drug recall
Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora…
FDA recall event 86063 · Class II · Maquiladora Miniara Sa De Cv
Key facts
| Event ID | 86063 |
|---|---|
| Recall numbers | D-1565-2020 |
| Recalling firm | Maquiladora Miniara Sa De Cv |
| Product type | Drugs |
| Products | Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol. |
| Initiation date | Jul 9, 2020 |
| Report date | Sep 16, 2020 |
| Termination date | Apr 24, 2024 |
| City | Coyotepec |
| Country | Mexico |
| FEI number | 3011856577 |
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: