The Recall Desk
HighFDA (Drugs)·D-0284-2023·Announced 2023-02-22

FDA Recalls D5 NS Injectable Solution for Lack of Sterility Assurance

Sentara Infusion Services is recalling D5 NS 2300mL, an injectable dextrose-saline solution, due to lack of sterility assurance. The product was dispensed to patients nationwide.

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 (injectable) product due to lack of sterility assurance. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Sentara Infusion Services is recalling D5 NS 2300mL, an injectable solution used in patient infusion therapy. The recall was initiated due to lack of sterility assurance of the product.

The affected product was dispensed to patients nationwide. The product's beyond-use date was December 26, 2022.

Patients who received this product should contact their healthcare provider or pharmacist for guidance. The product should not be used and should be returned to the pharmacy or healthcare provider.

The recalled product

Product
D5 NS 2300ML, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Manufacturer
Sentara Infusion Services
Category
Drug — Injectable Solution
Hazard
  • lack-of-sterility
  • infection-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 26
  • 2022

Distribution

Distributed nationwide across the United States.

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