# FDA recall D-0686-2020

> **Assurance Infusion** · Class II · drug recall initiated 2019-12-20.

## Product

BUP 15MG/HYDROM 5MG/ML  INJ in 20 mL syringe  Assurance Infusion (713) 533-8800

## Reason for recall

Lack of sterility assurance.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0686-2020
- **Recalling firm:** Assurance Infusion
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-12-20
- **Report date:** 2020-01-22
- **Termination date:** 2021-10-27

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0686-2020

## Citation

> AI Analytics. FDA recall D-0686-2020. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0686-2020. Source: US FDA. Licensed CC0.

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