# FDA recall D-0296-2025

> **QuVa Pharma, Inc.** · Class II · drug recall initiated 2025-03-06.

## Product

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75

## Reason for recall

Lack of Assurance of Sterility

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0296-2025
- **Recalling firm:** QuVa Pharma, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-06
- **Report date:** 2025-04-02

- **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-0296-2025

## Citation

> AI Analytics. FDA recall D-0296-2025. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0296-2025. Source: US FDA. Licensed CC0.

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