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
Reported: October 4, 2023 Initiated: August 22, 2023 #D-1177-2023
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
Reason for Recall
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Details
- Recalling Firm
- Sofie Co dba Sofie
- Units Affected
- 6 patient doses
- Distribution
- Product was released to one facility in VA.
- Location
- Sterling, VA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sofie Co dba Sofie. Units affected: 6 patient doses.
Why was this product recalled? ▼
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 4, 2023. Severity: Moderate. Recall number: D-1177-2023.
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