# FDA recall D-1084-2019

> **X-Gen Pharmaceuticals Inc.** · Class III · drug recall initiated 2019-03-29.

## Product

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

## Reason for recall

Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-1084-2019
- **Recalling firm:** X-Gen Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-29
- **Report date:** 2019-04-17
- **Termination date:** 2021-06-02

- **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-1084-2019

## Citation

> AI Analytics. FDA recall D-1084-2019. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/D-1084-2019. Source: US FDA. Licensed CC0.

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