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"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Fresenius Kabi USA, LLC
Reason for Recall:
Lack of Assurance of Sterility
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.

Product Codes/Lot Numbers:

Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0428-2026

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