Dextrose Injection Recalled Due to Lack of Sterility Assurance
Fresenius Kabi USA is recalling batch 6402165 of 5% Dextrose Injection (NDC 65219-458-05/30) due to lack of assurance of sterility. The batch was distributed nationwide through May 30, 2028 and should not be used.
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 risk-of-harm product (non-sterile intravenous medication poses serious infection risk), but no illnesses or injuries have been reported. Meets the rubric criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Fresenius Kabi USA, LLC is recalling one batch of 5% Dextrose Injection, USP (dextrose monohydrate, 50 mg/mL, 250 mL in freeflex bags) due to a lack of assurance of sterility. Batch 6402165, which expires May 30, 2028, was distributed nationwide, including Alaska and Puerto Rico.
This intravenous medication is used to provide energy and fluids to patients in medical settings. Non-sterile intravenous products can pose a risk of serious infection. Healthcare facilities in possession of units from this batch should discontinue use immediately.
Consumers who may have received an infusion from this recalled batch should contact their healthcare provider for guidance. Units should be returned to the manufacturer or disposed of in accordance with applicable regulations.
The recalled product
- Product
- DEXTROSE (DEXTROSE MONOHYDRATE)
- Brand
- DEXTROSE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Intravenous Injectable
- Hazard
- 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)
- Batch# 6402165
- Exp Date: 05/30/2028.
Distribution
Distributed nationwide across the United States.
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