Reported Apr 15, 2026 · Ongoing
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000…
Fresenius Kabi USA, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 3 Corporate Dr · Lake Zurich, IL · 60047-8930
Is this the product you have?
0.9% Sodium Chloride InjectionUSP900 mg per 100 mL (9 mg per mL) 1000 mL in a Single Dose freeflex bag1000 mLx10Fresenius Medical CareWalthamMA 02451
- Distributed byFresenius Medical Care RTG, LLC
- Manufactured byFresenius Kabi
- Unit of Use NDC65219-282-01
- Unit of Sale NDC Number65219-282-10
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 12/31/2026 2 Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027 3 Batch # 24EU10001, 24EU10002, Exp Date: 05/31/2027 4 Batch# 24PU10002, Exp Date: 11/30/2027 5 Batch# 25BU10003, Exp Date: 02/29/2028 6 Batch# 25EU10005, Exp Date: 05/31/2028.
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
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