Nafcillin Antibiotic Infusion Recalled Due to Sterility Assurance Failure
Sentara Infusion Services is recalling 16 bags of nafcillin antibiotic infusion nationwide due to lack of sterility assurance. Patients should contact their healthcare provider immediately.
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: FDA Class II recall of an injectable medication due to lack of sterility assurance. The source text explicitly reports no illnesses or hospitalizations, and the hazard is theoretical. However, injectable medication contamination presents serious potential for harm, justifying High severity.
Plain-English summary
Sentara Infusion Services is recalling nafcillin 24GM in normal saline 1200ML, an intravenous antibiotic medication. The recall affects 16 bags of this medication that were dispensed to patients nationwide.
The recall was initiated due to lack of sterility assurance. Nafcillin is an injectable antibiotic that must be sterile to be safe for patient use. If the sterility of the medication cannot be assured, there is a risk of microbial contamination that could cause serious infection.
Patients who received this medication should contact their healthcare provider or pharmacy immediately. The affected medication has a beyond-use date of December 25–31, 2022. Patients should not use any remaining supply of this medication without guidance from their healthcare provider.
The recalled product
- Product
- NAFCILLIN 24GM IN NS 1200ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable Antibiotic
- Affected units
- 16
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 25-31
- 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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