The Recall Desk
HighFDA (Drugs)·D-0320-2023·Announced 2023-02-22

TPN parenteral nutrition bags recalled due to lack of sterility

Sentara Infusion Services is recalling 31 TPN bags due to lack of sterility assurance. The recalled bags with Beyond Use Dates December 24–31, 2022, were dispensed nationwide to patients.

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 parenteral medication with lack of sterility assurance—a serious hazard for intravenous use. No illnesses or hospitalizations reported in source text; product meets rubric criterion for High severity as a risk-of-harm product without yet-reported injury.

Plain-English summary

Sentara Infusion Services is recalling TPN (Total Parenteral Nutrition) bags in multiple formulations due to a lack of sterility assurance. The recall involves 31 bags with Beyond Use Dates of December 24–31, 2022.

TPN is a nutritional formula administered directly into the bloodstream or intravenously. Lack of sterility assurance means the products may not have been manufactured under proper sterile conditions and could pose a risk of infection if contaminated.

The recalled products were dispensed nationwide to patients. Patients who received these products should contact their healthcare provider or pharmacy if they have questions about whether their TPN was affected.

The recalled product

Product
TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c) TPN AA: 100GM DEX: 105GM 2700ML, (d) TPN AA: 100GM DEX: 105GM LIP: 45GM 2700ML, (e) TPN: AA100GM ; DEX185GM ; LIP50GM IN 1500ML, (f) TPN: AA 150GM ; DEX 220GM ; LIP 45GM IN 2400 ml, (g) TPN
Manufacturer
Sentara Infusion Services
Hazard
  • sterility-defect
  • microbial-contamination

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 24-31
  • 2022

Distribution

Distributed nationwide across the United States.