FDA Drug recall D-218-2013
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVA…
- FDA Drug
- Class III
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class III recall of Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVA… by Hill Dermaceuticals, citing subpotent; 22 month stability timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-218-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-11-21 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hill Dermaceuticals |
| Distribution | US |
Product
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 Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04
Reason
Subpotent; 22 month stability timepoint
Identifiers
| code_info | Lot # D110550, Exp. 04/2013. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-218-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.