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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.

D-0429-2026

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-0429-2026

Official wording

Reason: Lack of Assurance of Sterility

Code information: Batch# 6402428, Exp Date: 10/31/2026; Batch# 6402481, 6402482, Exp Date: 11/30/2026.

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility