FDA Recalls TPN Nutrition Bags Due to Sterility Assurance Failure
Sentara Infusion Services recalls 24 bags of TPN (Total Parenteral Nutrition) distributed nationwide due to lack of sterility assurance. The recall affects prescription intravenous nutrition products.
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 an FDA Class II recall affecting parenteral nutrition, a risk-of-harm product due to lack of sterility assurance. No illnesses or injuries are reported in the source text, meeting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sentara Infusion Services has recalled 24 bags of TPN (Total Parenteral Nutrition) distributed to patients nationwide. The affected products include three formulations with varying compositions of amino acids, dextrose, and lipids, supplied in 1800ml, 2400ml, and 2300ml bags. These are prescription-only products designed for use with Curlin pumps for intravenous nutrition delivery.
The recall is due to a lack of sterility assurance. The affected bags have a Beyond Use Date of December 25-31, 2022. Parenteral nutrition products administered directly into the bloodstream must maintain strict sterility standards; contamination poses serious health risks.
The affected TPN bags have been dispensed to patients nationwide. Patients receiving TPN should contact their pharmacy or healthcare provider immediately if they have received any of the recalled products. Patients should not use any recalled TPN bags.
The recalled product
- Product
- TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c) TPN: AA 80GM ; DEX 320GM ; LIP 50GM IN 2300 ml, Rx only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Parenteral Nutrition
- Affected units
- 24
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 25-31
- 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.
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