August 2023 FDA Recall Neuraceq by Sofie Co Dba Sofie
D-1177-2023 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Sofie Co Dba Sofie on August 22, 2023 for the product Neuraceq. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Product was released to one facility in VA. and the recall is currently terminated.

Recall Number: D-1177-2023

Reason for Recall
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Initiated
08-22-2023
Reported
10-04-2023
Quantity
6 patient doses

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93073
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sofie Co dba Sofie
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was released to one facility in VA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2023
Product Description About Product Description
Full technical description of the 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

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

54828-001-30 Neuraceq
54828-001-50 Neuraceq