# FDA recall D-1189-2014

> **American Health Packaging** · Class II · drug recall initiated 2014-01-31.

## Product

HydrOXYzine HCl Tablets, USP  50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01

## Reason for recall

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an  unapproved source.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1189-2014
- **Recalling firm:** American Health Packaging
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-01-31
- **Report date:** 2014-04-09
- **Termination date:** 2015-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1189-2014

## Citation

> AI Analytics. FDA recall D-1189-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1189-2014. Source: US FDA. Licensed CC0.

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