Agency classClass IIOur severity:High FDA (Drugs)·D-0324-2023·Announced 2023-02-22

Vitamin K Injectable Syringes Recalled for Lack of Sterility Assurance

Sentara Infusion Services is recalling Vitamin K (Phytonadione) 2.5mg injectable syringes distributed nationwide due to lack of sterility assurance. Patients 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 a risk-of-harm product (injectable medication with sterility concerns) where no illnesses or injuries have been reported in the source text. While FDA Class II, the lack of sterility assurance on an injectable drug presents a significant theoretical risk, meeting the High severity criterion for risk-of-harm products without reported injury.

Plain-English summary

Sentara Infusion Services is recalling Vitamin K (Phytonadione) 2.5mg (0.25mL) injectable syringes due to lack of sterility assurance. The affected product has a beyond-use date of December 29, 2022, and was dispensed to patients nationwide.

Sterility is critical for injectable products. A lack of sterility assurance means the product may not meet required safety standards for injectable administration.

Patients who received this product should contact their healthcare provider or pharmacist immediately. Healthcare providers should discontinue use of any affected syringes and contact Sentara Infusion Services for guidance on replacement or alternative treatments.

The recalled product

Product: VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Manufacturer: Sentara Infusion Services
Category: Drug — Injectable / Vitamin
Hazard: lack-of-sterility
Affected units: 1

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 DateL 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.

See all 53 products in this recall →

Same manufacturer · Sentara Infusion Services

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