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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.

D-0427-2026

March 11, 2026

Class II

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 98581
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0427-2026

Official wording

Reason: Lack of Assurance of Sterility

Code information: Batch# 23SU10008, Exp Date: 12/31/2026; Batch# 24JU10003, Exp Date: 07/31/2027; Batch# 24LU10011, 24LU10012, Exp Date: 9/30/2027; Batch# 6402273, 6402275, Exp Date: 01/31/2028; Batch# 6402420, 6402421, 6402422, 6402423, Exp Date: 03/31/2028; Batch# 6402473, 6402474, 6402475, 6402476, 6402485, Exp Date: 04/30/2028; Batch# 6402516, Exp Date: 05/31/2028.

Distribution pattern: US Nationwide , Alaska, and Puerto Rico.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility