# FDA recall D-1646-2012

> **Hill Dermaceuticals, Inc.** · Class III · drug recall initiated 2012-05-08.

## Product

Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA ---  NDC 28105-149-04

## Reason for recall

Subpotent; fluocinolone acetonide

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1646-2012
- **Recalling firm:** Hill Dermaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-05-08
- **Report date:** 2012-08-22
- **Termination date:** 2015-02-10

- **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-1646-2012

## Citation

> AI Analytics. FDA recall D-1646-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1646-2012. Source: US FDA. Licensed CC0.

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