Drug recall
DermOtic Oil (fluocinolone acetonide) 0.01%, Ear Drops, For Otic Use Only, Not for Ophthalmic Use, Net Wt. 20…
FDA recall event 56744 · Class III · Hill Dermaceuticals, Inc.
Key facts
| Event ID | 56744 |
|---|---|
| Recall numbers | D-908-2010 |
| Recalling firm | Hill Dermaceuticals, Inc. |
| Product type | Drugs |
| Products | DermOtic Oil (fluocinolone acetonide) 0.01%, Ear Drops, For Otic Use Only, Not for Ophthalmic Use, Net Wt. 20 mL, bottle, Rx only, Manufactured and Distributed By: HILL DERMACEUTICALS, INC., Sanford… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent: The product is sub-potent prior to the expiration date. |
| Initiation date | Aug 9, 2010 |
| Termination date | Feb 3, 2011 |
| City | Sanford |
| State | FL |
| Country | United States |
| FEI number | 1036365 |
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