Drug recall
Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera…
FDA recall event 76611 · Class II · Fougera Pharmaceuticals Inc.
Key facts
| Event ID | 76611 |
|---|---|
| Recall numbers | D-0612-2017 |
| Recalling firm | Fougera Pharmaceuticals Inc. |
| Product type | Drugs |
| Products | Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream |
| Initiation date | Mar 2, 2017 |
| Report date | Mar 29, 2017 |
| Termination date | Jul 2, 2018 |
| City | Melville |
| State | NY |
| Country | United States |
| FEI number | 2432435 |
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: