Class II
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 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.
Lack of Assurance of Sterility
- Recall number
- D-0433-2026
- Report date
- April 15, 2026
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Fresenius Kabi USA, LLC
- Generic names
- SODIUM CHLORIDE
- Brand names
- SODIUM CHLORIDE
- Product NDCs
- 65219-282
Code and lot information
Batch# 23SU10001, Exp Date: 12/31/2026; Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027; Batch # 24EU10001, 24EU10002, Exp Date: 05/31/2027; Batch# 24PU10002, Exp Date: 11/30/2027; Batch# 25BU10003, Exp Date: 02/29/2028; Batch# 25EU10005, Exp Date: 05/31/2028.
Distribution
US Nationwide , Alaska, and Puerto Rico.
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.