KYTRIL Antiemetic Syringes Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling KYTRIL 350mcg syringes distributed nationwide due to lack of sterility assurance. Patients who received affected units should contact 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 a parenteral drug with lack of sterility assurance, posing a risk of bacterial or fungal infection. No illnesses or injuries have been reported, making this a risk-of-harm product without reported injury, which scores as High per the severity rubric.
Plain-English summary
Sentara Infusion Services has issued a recall of KYTRIL 350mcg in 3.5mL normal saline syringes manufactured for home infusion use. The recall affects 14 syringes that were dispensed to patients nationwide.
The recall was initiated due to lack of sterility assurance. Sterility is critical for injectable medications, as microbial contamination could potentially cause infection in patients receiving the medication.
Patients who received KYTRIL syringes with a beyond-use date of December 29, 2022, should immediately contact their healthcare provider or pharmacy. Do not use the affected syringes. Patients should consult their physician about alternative medication options or revised treatment plans.
The recalled product
- Product
- KYTRIL 350MCG IN 3.5ML NS SYRINGE, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Affected units
- 14
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 29
- 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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