Dextrose 10% TPN Solution Recalled Due to Sterility Assurance Concerns
Sentara Infusion Services is recalling Dextrose 10% 720ML TPN injectable solutions nationwide due to lack of sterility assurance. Patients using this product should contact their healthcare provider.
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 for injectable TPN solution with sterility assurance deficiencies. No illnesses or injuries have been reported in the source material. The hazard is theoretical—patients are at risk for infection from non-sterile product, but actual harm has not been documented.
Plain-English summary
Sentara Infusion Services is recalling Dextrose 10% 720ML TPN (Total Parenteral Nutrition) injectable solutions due to lack of sterility assurance. The recalled product was dispensed to patients nationwide.
The product is used with a home pump and requires a prescription. The recall affects units with a Beyond Use Date of December 28, 2022, manufactured by Sentara Infusion Services in Chesapeake, Virginia.
Patients who received this product should not use it and should contact their pharmacy or healthcare provider immediately for guidance. Do not continue using this product without consulting your healthcare provider.
The recalled product
- Product
- Dextrose 10% 720ML, TPN, Rx only, use with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Intravenous Solution
- Hazard
- sterility-assurance-failure
- 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 28
- 2022
Distribution
Distributed nationwide across the United States.
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