Fluconazole 200mg injection recalled due to sterility concerns
Sentara Infusion Services is recalling Fluconazole 200mg injectable solution due to lack of sterility assurance. The recall affects 13 bags distributed nationwide to patients.
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 a sterile injectable drug with lack of sterility assurance, representing a risk-of-harm product where no illnesses or injuries have been reported. The hazard is theoretical but potentially serious due to direct-to-bloodstream administration.
Plain-English summary
Sentara Infusion Services is recalling Fluconazole 200mg NS 100ml (an antifungal injectable medication) due to lack of sterility assurance. The product is an intravenous infusion used to treat fungal infections and is available by prescription only.
The recall involves 13 bags of the product that were dispensed directly to patients nationwide. The Beyond Use Date for the affected product is December 2-31, 2022. Sterility assurance is critical for injectable medications because any microbial contamination could potentially cause serious infections when administered directly into the bloodstream.
Patients who received this product should contact their healthcare provider or pharmacist immediately. Consumers should not use any remaining supply of this product. Healthcare providers should review patient records to identify anyone who may have received the recalled medication and take appropriate follow-up actions.
The recalled product
- Product
- FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable / Infusion
- Affected units
- 13
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 2-31
- 2022
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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