# FDA recall D-1066-2016

> **QuVa Pharma, Inc.** · Class I · drug recall initiated 2016-03-30.

## Product

PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only,  Healix Infusion Therapy Inc, 1075 W Park One Drive, Suite 200, Sugar Land Texas 77478, Product Code: 75901-1205-35.

## Reason for recall

Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.

## Distribution

CA

## Key facts

- **Recall number:** D-1066-2016
- **Recalling firm:** QuVa Pharma, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-03-30
- **Report date:** 2016-07-13
- **Termination date:** 2016-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sugar Land, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1066-2016

## Citation

> AI Analytics. FDA recall D-1066-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1066-2016. Source: US FDA. Licensed CC0.

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