---
title: "Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1... — FDA record D-1177-2023 | Is It on Recall"
description: "Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT)."
url: https://isitonrecall.com/recall/fda-drug-d-1177-2023-florbetaben-f-18-neuraceq-injection-solution-1-4-to-135-mci-ml-50-ml-in-1-multi-dose-glass-vial-diag/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For I... — FDA record D-1177-2023

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 Aug 22, 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**: Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only, Manufactured by SOFIE Co dba SOFIE, Dulles, VA 20166 for Life Molecular Imagining Ltd., NDC 54828-001-50
- **Reason**: Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
- **Classification**: Class II
- **Recalling firm**: Sofie Co dba Sofie
- **Quantity**: 6 patient doses
- **Agency-reported status**: Terminated
- **Source record identifier**: D-1177-2023

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1177-2023%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 | Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25 |

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

## Distribution

Product was released to one facility in VA.

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

- [Virginia](https://isitonrecall.com/state/virginia/)

## Dates in the source

- **Report date**: Oct 4, 2023
- **Recall initiation date**: Aug 22, 2023
- **Center classification date**: Sep 26, 2023
- **Termination date**: Dec 4, 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-1177-2023%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/) [Sofie Co dba Sofie records](https://isitonrecall.com/brand/sofie-co-dba-sofie/)