The Recall Desk
HighFDA (Drugs)·D-0319-2023·Announced 2023-02-22

FDA Class II: TPN solution bags lack sterility assurance

Sentara Infusion Services is recalling 111 bags of TPN (Total Parenteral Nutrition) solution due to lack of sterility assurance. Products 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: This is an FDA Class II drug recall for lack of sterility assurance in an intravenous product. No illnesses or injuries have been reported in the source material. According to the severity rubric, Class II recalls without reported hospitalization constitute a risk-of-harm product where injury has not yet been reported, corresponding to Score 3 (High).

Plain-English summary

Sentara Infusion Services is recalling 111 bags of TPN (Total Parenteral Nutrition) solution with various formulations. These intravenous nutritional solutions were prepared and dispensed by Sentara Home Infusion Pharmacy Services in Chesapeake, Virginia.

The recall was initiated due to lack of sterility assurance. Sterility is critical for intravenous products because non-sterile solutions could introduce contamination directly into the bloodstream.

The affected products were distributed nationwide and dispensed to patients. The beyond-use date for the affected products was December 24-31, 2022.

Patients who received these TPN solutions should contact their healthcare provider or pharmacist immediately. Healthcare providers should review patient records for products dispensed within the affected beyond-use date range and advise patients of potential exposure.

The recalled product

Product
TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c) 108GM/AA, 330GM/DEX, 60GM/LIP 3000ML, (d) 37GM/AA, 160GM/DEX 1450ML, (e) 37GM/AA, 160GM/DEX, 25GM/LIP 1450ML, (f) 74-100GM OF PROTEIN B4197 74 Gm, (g) 75GM/AA, 200GM/DEX, 43GM/LIP 2500ML, (h) 90GM/AA ;
Manufacturer
Sentara Infusion Services
Category
Drug — Parenteral Nutrition
Hazard
  • contamination-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 24-31
  • 2022

Distribution

Distributed nationwide across the United States.

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