Caspofungin Injectable Medication Recalled for Sterility Assurance Issues
Sentara Infusion Services is recalling Caspofungin 50mg injectable bags dispensed nationwide due to lack of sterility assurance. Patients should consult their healthcare provider.
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 is an FDA Class II recall of injectable medication. While sterility assurance issues in injectable drugs present a significant risk of infection, no illnesses or injuries have been reported in the source material. The recall represents a risk-of-harm situation where injury has not yet been reported.
Plain-English summary
Sentara Infusion Services is recalling seven bags of Caspofungin 50mg in normal saline (100ml) that were dispensed to patients nationwide. The medication was administered using a Homepump device.
The recall is due to a lack of sterility assurance, which means the preparation may not meet required sterilization standards. This poses a potential risk of contamination for patients who received this medication. Affected batches have a beyond-use date of December 30-31, 2023.
Patients who received this medication should contact their healthcare provider immediately to discuss whether they were affected and to determine if any medical follow-up is needed.
The recalled product
- Product
- CASPOFUNGIN 50MG IN NS 100ML, used with a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable / Intravenous
- Affected units
- 7
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 (2)
- Beyond Use Date: December 30-31
- 2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 53 recalled by Sentara Infusion Services under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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