# FDA recall D-0295-2016

> **Akorn, Inc.** · Class III · drug recall initiated 2015-08-21.

## Product

Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10

## Reason for recall

Defective Container: Product missing safety seal around the neck of the bottle.  The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing."  Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0295-2016
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-08-21
- **Report date:** 2015-11-25
- **Termination date:** 2017-11-29

- **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-0295-2016

## Citation

> AI Analytics. FDA recall D-0295-2016. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0295-2016. Source: US FDA. Licensed CC0.

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