FDA Drug recall D-1646-2012
Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manu…
- FDA Drug
- Class III
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class III recall of Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manu… by Hill Dermaceuticals, citing subpotent; fluocinolone acetonide.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1646-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-05-08 |
| Published | 2012-08-22 |
| 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), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04
Reason
Subpotent; fluocinolone acetonide
Identifiers
| code_info | Lot Numbers: -Scalp Oil: H100084 (exp 08/12), H100086 (08/12), J100093 (exp 08/12), J100094 (exp 09/12), J100097 (exp…Lot Numbers: -Scalp Oil: H100084 (exp 08/12), H100086 (08/12), J100093 (exp 08/12), J100094 (exp 09/12), J100097 (exp 09/12), K100101 (exp 09/12), K100103 (exp 10/12), K100104 (exp 10/12), K100108 (exp 10/12), K100112 (exp 10/12), L100860 (exp 11/12), L100890 (exp 11/12), L100910 (exp 11/12). |
|---|
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-1646-2012%22
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