# FDA recall D-1032-2014

> **KVK-Tech, Inc.** · Class II · drug recall initiated 2013-12-11.

## Product

HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC,  Newtown, PA 18940.  100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10.

## Reason for recall

Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

## Distribution

Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.

## Key facts

- **Recall number:** D-1032-2014
- **Recalling firm:** KVK-Tech, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-12-11
- **Report date:** 2014-01-29
- **Termination date:** 2015-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newtown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1032-2014

## Citation

> AI Analytics. FDA recall D-1032-2014. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1032-2014. Source: US FDA. Licensed CC0.

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