NEURACEQ diagnostic drug recalled for sterility assurance test failure
A batch of NEURACEQ (florbetaben F-18), a radioactive diagnostic drug, was recalled by Sofie after failing sterility assurance testing. The affected batch was distributed to one facility in Virginia.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a potential sterility failure in an intravenous drug with no reported illnesses or injuries. The hazard is theoretical rather than confirmed contamination, and no patients have been harmed to date.
Plain-English summary
NEURACEQ (florbetaben F-18) is an intravenous radioactive diagnostic drug manufactured by Sofie Co. The recalled batch (number FBBVA123082201) contained six patient doses in a 50-mL multi-dose vial.
The manufacturer recalled the batch due to out-of-specification results on the Filter Integrity Test (FIT), which is used to assure a product is sterile. The failure to meet specifications means the manufacturer could not confirm the product met required sterility standards.
The affected batch was distributed to one facility in Virginia. The batch had an end-of-shelf-life of August 22, 2023, at 08:25 and an expiration of August 22, 2023, at 18:25.
The recalled product
- Product
- NEURACEQ (FLORBETABEN F 18)
- Brand
- NEURACEQ
- Manufacturer
- Sofie Co dba Sofie
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Batch # FBBVA123082201
- EOS: 22 Aug 2023/08:25
- EXP: 22 Aug 2023/18:25
Distribution
Distributed in 1 state:
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