# FDA recall D-0048-2015

> **Hi-Tech Pharmacal Co., Inc.** · Class II · drug recall initiated 2014-04-01.

## Product

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702-052-16, Rx Only, Manufactured for: KVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.

## Reason for recall

Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.

## Distribution

nationwide

## Key facts

- **Recall number:** D-0048-2015
- **Recalling firm:** Hi-Tech Pharmacal Co., Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-01
- **Report date:** 2014-11-05
- **Termination date:** 2016-09-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Amityville, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0048-2015

## Citation

> AI Analytics. FDA recall D-0048-2015. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0048-2015. Source: US FDA. Licensed CC0.

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