Drug recall
Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc…
FDA recall event 64455 · Class III · Hill Dermaceuticals, Inc.
Key facts
| Event ID | 64455 |
|---|---|
| Recall numbers | D-217-2013, D-218-2013 |
| Recalling firm | Hill Dermaceuticals, Inc. |
| Product type | Drugs |
| Products | Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04, Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent; 12 month stability timepoint, Subpotent; 22 month stability timepoint |
| Initiation date | Nov 21, 2012 |
| Report date | Apr 3, 2013 |
| Termination date | May 28, 2013 |
| 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 · Source date: