FDA Drug recall D-1647-2012
Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distribut…
- 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%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distribut… by Hill Dermaceuticals, citing subpotent; fluocinolone acetonide.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1647-2012 |
| 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%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04
Reason
Subpotent; fluocinolone acetonide
Identifiers
| code_info | Lot Numbers: -Body Oil: J100095 (exp 09/12), J100099 (exp 09/12), K100106 (exp 10/12), K100111 (exp 10/12), L100872 (…Lot Numbers: -Body Oil: J100095 (exp 09/12), J100099 (exp 09/12), K100106 (exp 10/12), K100111 (exp 10/12), L100872 (exp 11/12), L100880 (exp 11/12), D110560 (exp 04/13). |
|---|
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-1647-2012%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.