# FDA recall D-0551-2020

> **QuVa Pharma, Inc.** · Class II · drug recall initiated 2019-11-12.

## Product

fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478  NDC 70092-1099-49

## Reason for recall

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0551-2020
- **Recalling firm:** QuVa Pharma, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-11-12
- **Report date:** 2019-12-11
- **Termination date:** 2020-06-05

- **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-0551-2020

## Citation

> AI Analytics. FDA recall D-0551-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0551-2020. Source: US FDA. Licensed CC0.

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