# FDA recall D-0945-2023

> **SCA Pharmaceuticals** · Class II · drug recall initiated 2023-07-20.

## Product

FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40

## Reason for recall

cGMP deviations: due to shipment of rejected units.

## Distribution

KY and NJ

## Key facts

- **Recall number:** D-0945-2023
- **Recalling firm:** SCA Pharmaceuticals
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-07-20
- **Report date:** 2023-08-02
- **Termination date:** 2023-09-21

- **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-0945-2023

## Citation

> AI Analytics. FDA recall D-0945-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0945-2023. Source: US FDA. Licensed CC0.

---

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