Moderate riskFDA DrugClass II

Fresenius Kabi sodium chloride injection recalled for sterility concerns

Fresenius Kabi USA is recalling a specific batch of 0.9% Sodium Chloride Injection (a sterile saline solution used in medical settings) because the manufacturer cannot guarantee it remained sterile during production. The affected batch (24EU10010) was distributed nationwide, including Alaska and Puerto Rico.

From the FDA notice · Read the official notice ↗ · All Fresenius Kabi recalls

What to do

  1. If you have batch #24EU10010 (expiration 05/31/2027), stop using it immediately
  2. Contact your healthcare provider or pharmacy to confirm whether you have received this batch
  3. Do not use this medication; return it to the pharmacy or healthcare facility

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.
Sold in
Nationwide
Made for
All ages (under 100 years)

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-0434-2026

In the FDA's words

Description
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 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07. Lack of Assurance of Sterility Batch# 24EU10010, Exp Date: 05/31/2027. 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.

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