HIGH

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 Kabi"), Lake Zurich, IL 600047, Unit of Use...

Lack of Assurance of Sterility

Quick Facts at a Glance

Recall Date
March 11, 2026
Hazard Level
HIGH
Brands
SODIUM CHLORIDE, Fresenius Kabi USA, LLC
Geographic Scope
1 states

Hazard Information

Lack of Assurance of Sterility

What You Should Do

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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Full Description

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 Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50.. Generic: SODIUM CHLORIDE; Brand: SODIUM CHLORIDE. Reason: Lack of Assurance of Sterility. Classification: Class II. Distribution: US Nationwide , Alaska, and Puerto Rico.

Safety Guide

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Product Classification

Product Details

Model Numbers
Batch# 6402299
6402300
6402301
6402302
6402303
+9 more
UPC Codes
65219-466
65219-468
65219-470
+12 more
Affected States
ALL
Report Date
April 15, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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BD and Fresenius Kabi Sodium Chloride Injection Recalled for Lack of Sterility Assurance (2026)

BD Becton, Dickinson and Company and Fresenius Kabi USA recall 0.9% Sodium Chloride Injection, USP, 250 mL in a single-dose bag nationwide, including Alaska and Puerto Rico. The recall cites lack of assurance of sterility. Healthcare providers and patients should stop using the product immediately and follow guidance from Fresenius Kabi or their provider.

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