Neuraceq Injection, Solution
FDA Recall NDC 54828-001
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Neuraceq (NDC 54828-001). A significant event, classified as Class II, was initiated on Aug 22, 2023 by Lantheus Biosciences Ltd.. The reported reason for this action was: "Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT)."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Aug 22, 2023
Oct 04, 2023
6 patient doses
Recall Profile & Regulatory Data
Event ID
93073
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sofie Co dba Sofie
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was released to one facility in VA.
Termination Date
Dec 04, 2023
Product Description
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
Batch or Lot Expiration Information
Batch# FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25
Affected Packages Involved in this Recall
54828-001-30Product
54828-001-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
