Fresenius Kabi USA recalled 0.9% Sodium Chloride Injection nationwide, including Alaska and Puerto Rico. The recall is due to lack of assurance of sterility. Healthcare providers should stop using the product immediately and contact Fresenius Kabi for guidance.
Lack of Assurance of Sterility
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for guidance. Notification method: Letter
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0.9% Sodium Chloride Injection is an intravenous sterile saline solution used in medical settings for fluid and electrolyte management.
Lack of sterility assurance means there could be contamination, posing infection risk if administered intravenously.
This recall is not necessarily part of a broader industry pattern, based on available data.
For patients, this recall could interrupt IV therapy and require replacement products, potentially delaying treatment.
Product packaging and labeling will list NDC numbers, batch numbers, and expiration dates.
Refunds or replacements are issued per Fresenius Kabi guidance; processing could take several weeks.
Keep the recall notice, batch records, and any correspondence with Fresenius Kabi and healthcare facilities.
Brand: Fresenius Kabi USA, LLC. Product: 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) 50 mL. Route: Rx only. Unit of Use NDC: 65219-466-05. Unit of Sale NDC: 65219-466-60. Batch numbers: 6402372, 6402374, 6402437. Expiration dates: 08/31/2026 and 10/31/2026. Sold nationwide in the US, including Alaska and Puerto Rico.
No specific injuries or incidents are described in the provided data.
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