Fresenius Kabi 100 mL dextrose injection bags recalled over sterility assurance
Fresenius Kabi is recalling three batches of 5% Dextrose Injection, USP, 5 g per 100 mL in freeflex bags, citing lack of assurance of sterility.
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 sterile injectable where sterility cannot be assured, a risk of harm with no illnesses reported in the source.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 5% Dextrose Injection, USP, 5 g per 100 mL (50 mg per mL), supplied as 100 mL in a 100 mL freeflex bag. The unit of use NDC is 65219-464-05 and the unit of sale NDC is 65219-464-50.
The stated reason is lack of assurance of sterility. Sterility is a defining requirement of an injectable product because it is introduced directly into the bloodstream or tissue. The FDA classified the action as Class II.
Affected batches are 6402399, 6402400 and 6402401, all expiring 02/28/2027. Distribution was US nationwide, including Alaska and Puerto Rico.
This is a prescription product supplied to healthcare facilities. Facilities should check stock against the batch numbers above, quarantine affected bags and follow the instructions issued by Fresenius Kabi.
The recalled product
- Product
- DEXTROSE (DEXTROSE MONOHYDRATE)
- Brand
- DEXTROSE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable solution
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 (4)
- Batch# 6402399
- 6402400
- 6402401
- Exp Date: 02/28/2027.
Distribution
Part of a larger recall action
This product is one of 14 recalled by Fresenius Kabi USA, LLC 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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