# FDA recall D-1544-2022

> **QuVa Pharma, Inc.** · Class III · drug recall initiated 2022-09-20.

## Product

oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07.

## Reason for recall

Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1544-2022
- **Recalling firm:** QuVa Pharma, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-09-20
- **Report date:** 2022-10-05
- **Termination date:** 2023-02-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomsbury, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1544-2022

## Citation

> AI Analytics. FDA recall D-1544-2022. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-1544-2022. Source: US FDA. Licensed CC0.

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