Drug recall
Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%)…
FDA recall event 78595 · Class II · EAI-JR286 INC
Key facts
| Event ID | 78595 |
|---|---|
| Recall numbers | D-0100-2018 |
| Recalling firm | EAI-JR286 INC |
| Product type | Drugs |
| Products | Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity. |
| Initiation date | Nov 28, 2017 |
| Report date | Dec 6, 2017 |
| Termination date | Aug 9, 2019 |
| City | Torrance |
| State | CA |
| Country | United States |
| FEI number | 3012689186 |
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: