# FDA recall D-610-2013

> **Hill Dermaceuticals, Inc.** · Class III · drug recall initiated 2013-05-07.

## 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 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-610-2013
- **Recalling firm:** Hill Dermaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-07
- **Report date:** 2013-07-03
- **Termination date:** 2013-07-19

- **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-610-2013

## Citation

> AI Analytics. FDA recall D-610-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-610-2013. Source: US FDA. Licensed CC0.

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