INTRALIPID 18GM Parenteral Nutrition Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling 7 bags of INTRALIPID 18GM, a parenteral nutrition solution, due to lack of sterility assurance. The product was dispensed to patients nationwide.
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: FDA Class II recall of an injectable parenteral nutrition product with sterility assurance failure. No illnesses or injuries are reported in the source text. This represents a risk-of-harm product (non-sterile injectable solutions risk serious infection) without confirmed patient impact, meeting the High severity criterion.
Plain-English summary
INTRALIPID 18GM is a parenteral nutrition (TPN) solution containing lipid emulsion used for intravenous feeding. The product is intended for use with a Curlin pump as prescribed by healthcare providers.
Sentara Infusion Services has recalled 7 bags of INTRALIPID 18GM due to lack of sterility assurance. This means the product may not meet required standards for safety as an injectable medication. Affected bags have a Beyond Use Date of December 29-30, 2022.
The recalled product was dispensed to patients nationwide. Patients who received this medication should contact their healthcare provider or pharmacy immediately. Do not use this product. Your healthcare provider will advise on next steps and whether any monitoring is necessary.
The recalled product
- Product
- INTRALIPID 18GM, TPN, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
- Manufacturer
- Sentara Infusion Services
- Affected units
- 7
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.
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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