Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intr
Summary
The FDA issued a Class II for Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 mu by Sofie Co dba Sofie. Reason: Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT)..
Details
Source
Drug Recall
External ID
D-1177-2023
Action Date
2023-10-04
Status
Terminated
Category
drug
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
Lot/Code Info: Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25
Quantity Affected: 6 patient doses
Reason for Recall
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Distribution
Product was released to one facility in VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-22
Company
Sterling, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 38 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sofie Co dba Sofie) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sofie Co dba Sofie have FDA actions?
This is the only FDA action we have on record for Sofie Co dba Sofie in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1177-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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