Sofie Co dba Sofie 2023-10-04 Health serious FDA
Health · FDA · Recall #FDA-D-1177-2023
Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose… Recall
Issued October 4, 2023 · Sofie Co dba Sofie
In October 2023, Sofie Co dba Sofie recalled the Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
What you should do
- 1 Stop using Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Sofie Co dba Sofie to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Sofie Co dba Sofie
- Category
- Health
- Recall date
- October 4, 2023
- Units affected
- Not reported
- Sold at
- Product was released to one facility in VA.
- Recall number
- FDA-D-1177-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Sofie Co dba Sofie has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.