Fresenius Kabi sodium chloride injection recalled for sterility assurance
Fresenius Kabi is recalling one batch of 0.45% sodium chloride injection (saline solution) used in hospitals and medical facilities because the manufacturer cannot guarantee the product is sterile. The affected batch is #6402413 with an expiration date of 02/29/2028. No infections or injuries have been reported so far.
From the FDA notice · Read the official notice ↗ · All Fresenius Kabi recalls
What to do
- If you work in a hospital or medical facility, stop using batch #6402413 immediately.
- Contact Fresenius Kabi or your medical supplier about returning the affected product.
- Report any use of this batch to your healthcare provider or pharmacist.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 14 products — see all of them.
Details
- Illnesses reported
- None reported
- Manufactured in
- 3 Corporate Dr, Lake Zurich, IL, United States
- Classification
- Class II
- Recall number
- D-0424-2026
In the FDA's words
- Description
- 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case). Lack of Assurance of Sterility Batch # 6402413, Exp Date: 02/29/2028 Distribution: US Nationwide , Alaska, and Puerto Rico.
- Hazard
- Lack of Assurance of Sterility
14 products in this recall
Fresenius Kabi IV saline and dextrose bags recalled over sterility
Fresenius Kabi is recalling 14 sodium chloride and dextrose IV fluid bags because the company cannot assure they are sterile. The products were sold under the Fresenius Kabi, BD and Fresenius Medical Care names and were distributed nationwide, to Alaska and to Puerto Rico. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius K… (this page)D-0424-2026
- 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047,…D-0425-2026
- 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kab…D-0426-2026
- 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi")…D-0427-2026
- 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi")…D-0428-2026
- 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured b…D-0429-2026
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckto…D-0430-2026
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton…D-0431-2026
- 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA,…D-0432-2026
- 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…D-0433-2026
- 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becto…D-0434-2026
- 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-…D-0435-2026
- 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-…D-0436-2026
- 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 652…D-0437-2026
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