---
title: "FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL ... — FDA record D-0945-2023 | Is It on Recall"
description: "cGMP deviations: due to shipment of rejected units."
url: https://isitonrecall.com/recall/fda-drug-d-0945-2023-fentanyl-500-mcg-250-ml-bupivacaine-hcl-0-1-in-0-9-sodium-chloride-250ml-bag-injection-for-epidural/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNY... — FDA record D-0945-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 20, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: cGMP deviations: due to shipment of rejected units.
- **Classification**: Class II
- **Recalling firm**: SCA Pharmaceuticals
- **Quantity**: 183 bags
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0945-2023

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0945-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot # 1223047134, Use By: 09/21/2023 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

KY and NJ

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)

## Dates in the source

- **Report date**: Aug 2, 2023
- **Recall initiation date**: Jul 20, 2023
- **Center classification date**: Jul 26, 2023
- **Termination date**: Sep 21, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0945-2023%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [SCA Pharmaceuticals records](https://isitonrecall.com/brand/sca-pharmaceuticals/)