# FDA recall D-218-2013

> **Hill Dermaceuticals, Inc.** · Class III · drug recall initiated 2012-11-21.

## 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

## Distribution

Nationwide

## Key facts

- **Recall number:** D-218-2013
- **Recalling firm:** Hill Dermaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-11-21
- **Report date:** 2013-04-03
- **Termination date:** 2013-05-28

- **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-218-2013

## Citation

> AI Analytics. FDA recall D-218-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-218-2013. Source: US FDA. Licensed CC0.

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