FDA Drug recall D-008-2014
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed…
- FDA Drug
- Class III
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class III recall of Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed… by Hill Dermaceuticals, citing subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-008-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-09-08 |
| Published | 2013-11-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hill Dermaceuticals |
| Distribution | US |
Product
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04.
Reason
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Identifiers
| code_info | K111100 exp.10/13, K111110 exp.10/13, M111240 exp.12/13, and A120012 exp.01/14 |
|---|
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-008-2014%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.