Derma-Smoothe/FS — Class III drug recall D-218-2013
Terminated recall by Hill Dermaceuticals, Inc., reported 2013-04-03, distributed nationwide. Subpotent; 22 month stability timepoint
| Recall number | D-218-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hill Dermaceuticals, Inc., Sanford, FL, United States |
| Recall initiated | 2012-11-21 |
| Classified | 2013-03-22 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2013-05-28 |
| Distributed | Nationwide (US) |
| Quantity | 8,592 bottles |
| Reason classes | potency, specification failure |
| NDC | 28105-0149-04 |
| Lot numbers | D110550 |
| Expiration dates | 2013-04 |
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 for recall
Subpotent; 22 month stability timepoint
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-218-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.