Why it was recalled
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
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 numbers, UPCs & expiration codes
Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25
Where it was sold
Product was released to one facility in VA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1177-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2023
- FDA report date
- Oct 4, 2023
- Quantity
- 6 patient doses
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sofie Co dba Sofie
Original FDA data
Every field from FDA enforcement report D-1177-2023, exactly as published.
Show all FDA fields
- City
- Sterling
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 93073
- Address
- 100 Executive Dr Ste 6
- Code information
- Batch # FBBVA123082201, EOS: 22 Aug 2023/08:25, EXP: 22 Aug 2023/18:25
- Postal code
- 20166-9507
- Report date
- Oct 4, 2023
- Product type
- Drugs
- Recall number
- D-1177-2023
- Classification
- Class II
- Recalling firm
- Sofie Co dba Sofie
- Product quantity
- 6 patient doses
- Termination date
- Dec 4, 2023
- Reason for recall
- Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was released to one facility in VA.
- Recall initiation date
- Aug 22, 2023
- Initial firm notification
- Telephone
- Center classification date
- Sep 26, 2023