FDA Drug recall D-610-2013
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distribu…
- FDA Drug
- Class III
- terminated
- Published 2013-07-03
On 2013-07-03 the FDA classified a Class III recall of Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distribu… 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-610-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-05-07 |
| Published | 2013-07-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hill Dermaceuticals |
| Distribution | US |
Product
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.
Reason
Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Identifiers
| code_info | Lot #: H110940, Exp 08/13 |
|---|
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-610-2013%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.