# FDA recall D-1011-2019

> **Akorn Inc** · Class II · drug recall initiated 2019-03-12.

## Product

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701.  NDC: 50383-901-10

## Reason for recall

Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-1011-2019
- **Recalling firm:** Akorn Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-12
- **Report date:** 2019-03-27
- **Termination date:** 2022-08-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1011-2019

## Citation

> AI Analytics. FDA recall D-1011-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-1011-2019. Source: US FDA. Licensed CC0.

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