The Recall Desk
HighFDA (Drugs)·D-0312-2023·Announced 2023-02-22

Ondansetron 8mg Injectable Recalled for Lack of Sterility Assurance

Sentara Infusion Services is recalling ondansetron 8mg injectable doses due to lack of sterility assurance. The medication was dispensed to patients nationwide with a beyond use date of December 29-30, 2022.

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: FDA Class II recall of a sterile injectable where sterility assurance failed. This is a risk-of-harm product; however, no illnesses or injuries are reported and the hazard remains theoretical. Per the rubric, risk-of-harm products without reported injury score as High.

Plain-English summary

Sentara Infusion Services is recalling 15 bags of ondansetron 8mg in normal saline (100ml), a prescription injectable medication used to prevent nausea and vomiting. The recall is due to lack of sterility assurance.

The affected product was dispensed to patients nationwide. The beyond use date for the recalled doses is December 29-30, 2022.

Patients who have received this medication should contact their prescribing healthcare provider or pharmacist immediately. Do not use any remaining doses of this product. No illnesses have been reported in connection with this recall.

The recalled product

Product
ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Manufacturer
Sentara Infusion Services
Category
Drug — Injectable / Intravenous
Hazard
  • lack-of-sterility

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 29-30
  • 2022

Distribution

Distributed nationwide across the United States.

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