The Recall Desk
HighFDA (Drugs)·D-0299-2023·Announced 2023-02-22

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.

What this means for you

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
Hazard
  • sterility-failure
  • contamination-risk

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.