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Recall Observatory FDA recall evidence

Drug product

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.

D-0431-2026

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-0431-2026

Official wording

Reason: Lack of Assurance of Sterility

Code information: Batch# 6402290, 6402291, Exp Date: 01/31/2028; Batch# 6402411, Exp Date: 02/29/2028; Batch# 6402412, 6402419, 6402424, 6402425, 6402426, 6402427, Exp Date: 03/31/2028; Batch# 6402479, 6402480, 6402517, 6402571, Exp Date: 05/31/2028; Batch# 6402518, Exp Date: 06/30/2028.

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility