Drug recall
3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package…
FDA recall event 80730 · Class II · 3M Company - Health Care Business
Key facts
| Event ID | 80730 |
|---|---|
| Recall numbers | Z-0368-2019 |
| Recalling firm | 3M Company - Health Care Business |
| Product type | Devices |
| Products | 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product. |
| Initiation date | Jul 6, 2018 |
| Report date | Nov 7, 2018 |
| Termination date | Feb 26, 2019 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 2110898 |
At a glance
- 1–9 Products in this recall
- 10–99 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: