# FDA recall D-007-2014

> **Hill Dermaceuticals, Inc.** · Class III · drug recall initiated 2013-09-08.

## Product

Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-149-04.

## Reason for recall

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-007-2014
- **Recalling firm:** Hill Dermaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-09-08
- **Report date:** 2013-11-27
- **Termination date:** 2014-08-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sanford, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-007-2014

## Citation

> AI Analytics. FDA recall D-007-2014. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-007-2014. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*