FDA-Drug2026-04-15Class IIPROCESSING DEFECT

Fresenius Kabi sodium chloride injection recalled for sterility concerns

OTHERNationwide distributionDrugs

What this means

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.

  • If you have batch #24EU10010 (expiration 05/31/2027), stop using it immediately
  • Contact your healthcare provider or pharmacy to confirm whether you have received this batch
  • Do not use this medication; return it to the pharmacy or healthcare facility
The agency's original wording
Hazard

Lack of Assurance of Sterility

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide , Alaska, and Puerto Rico.
Manufactured in
3 Corporate Dr, Lake Zurich, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0434-2026

More Fresenius Kabi recalls

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