# FDA recall D-603-2013

> **Hi-Tech Pharmacal Co., Inc.** · Class III · drug recall initiated 2013-04-30.

## Product

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16

## Reason for recall

Subpotent; 24 month stability test station

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-603-2013
- **Recalling firm:** Hi-Tech Pharmacal Co., Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-04-30
- **Report date:** 2013-06-26
- **Termination date:** 2016-05-13

- **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-603-2013

## Citation

> AI Analytics. FDA recall D-603-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-603-2013. Source: US FDA. Licensed CC0.

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