# FDA recall D-0190-2021

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

## Product

Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe,  Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd.,  Windsor, CT, 06095, barcode 70004062012

## 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-0190-2021
- **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-0190-2021

## Citation

> AI Analytics. FDA recall D-0190-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0190-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*