The Recall Desk
HighFDA (Drugs)·D-0285-2023·Announced 2023-02-22

Intravenous hydration solution recalled for lack of sterility assurance

Sentara Infusion Services is recalling D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML intravenous hydration solution due to lack of sterility assurance. Eight bags were 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 drug recall for lack of sterility assurance in an intravenous infusion product. No illnesses or injuries have been reported in the source text. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, which corresponds to a severity score of 3 (High).

Plain-English summary

Sentara Infusion Services is recalling D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, an intravenous hydration solution, due to lack of sterility assurance. Eight bags of this product were dispensed to patients nationwide.

Patients who received this medication should contact their healthcare provider immediately and do not use this product. The lack of sterility assurance in intravenous infusions poses a potential risk of infection or other serious complications.

The affected product has a beyond-use date of December 29-31, 2022.

The recalled product

Product
D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, Hydration, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Manufacturer
Sentara Infusion Services
Hazard
  • sterility-failure
  • 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 29-31
  • 2022

Distribution

Distributed nationwide across the United States.