# FDA recall D-0193-2021

> **SCA Pharmaceuticals** · Class II · drug recall initiated 2020-12-17.

## Product

fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016

## Reason for recall

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

## Distribution

Product was distributed to hospitals nationwide.

## Key facts

- **Recall number:** D-0193-2021
- **Recalling firm:** SCA Pharmaceuticals
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-12-17
- **Report date:** 2021-01-13
- **Termination date:** 2021-11-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Windsor, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0193-2021

## Citation

> AI Analytics. FDA recall D-0193-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0193-2021. Source: US FDA. Licensed CC0.

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