Drug recall
Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi…
FDA recall event 62520 · Class II · Westone Laboratories, Inc.
Key facts
| Event ID | 62520 |
|---|---|
| Recall numbers | Z-2058-2012 |
| Recalling firm | Westone Laboratories, Inc. |
| Product type | Devices |
| Products | Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product. |
| Initiation date | Jul 13, 2012 |
| Report date | Aug 1, 2012 |
| Termination date | Dec 14, 2012 |
| City | Colorado Springs |
| State | CO |
| Country | United States |
| FEI number | 2094377 |
At a glance
- 1–9 Products in this recall
- 1–9 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: