# FDA recall D-1129-2015

> **Akorn, Inc.** · Class II · drug recall initiated 2015-04-07.

## Product

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by  Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide including Puerto Rico

## Key facts

- **Recall number:** D-1129-2015
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-07
- **Report date:** 2015-06-17
- **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-1129-2015

## Citation

> AI Analytics. FDA recall D-1129-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1129-2015. Source: US FDA. Licensed CC0.

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