Florbetaben F-18 recall: Sterility Concern
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…
Why was Florbetaben F-18 recalled?
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25
- 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…
- Recalling firm
- Sofie Co dba Sofie
- Quantity
- 6 patient doses
- Distribution
- Product was released to one facility in VA.
- Recall date
- October 4, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)