# FDA recall D-1444-2014

> **X-Gen Pharmaceuticals Inc.** · Class III · drug recall initiated 2014-07-17.

## Product

Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY  14814, NDC 39822-2000-1.

## Reason for recall

Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1444-2014
- **Recalling firm:** X-Gen Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-07-17
- **Report date:** 2014-07-30
- **Termination date:** 2015-10-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1444-2014

## Citation

> AI Analytics. FDA recall D-1444-2014. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1444-2014. Source: US FDA. Licensed CC0.

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