# FDA recall D-0637-2021

> **Hill Dermaceuticals, Inc.** · Class II · drug recall initiated 2021-05-21.

## Product

DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops  20 mL bottles, Rx only,  Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20

## Reason for recall

Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0637-2021
- **Recalling firm:** Hill Dermaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-05-21
- **Report date:** 2021-06-30
- **Termination date:** 2022-09-28

- **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-0637-2021

## Citation

> AI Analytics. FDA recall D-0637-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0637-2021. Source: US FDA. Licensed CC0.

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