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WarningRecall #D-0431-2026Drug / Pharmaceutical

Fresenius Kabi USA Recalls 0

Fresenius Kabi USA, LLC · Class II — Moderate Risk

Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
An assortment of pharmaceutical pills (representative file photo). Specific recalled product: see recall details below. Photo: Michael Nutt / Wikimedia Commons (CC BY-SA 2.0).

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility

FDA Classification

Class II — Moderate Risk

A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Distribution

US Nationwide , Alaska, and Puerto Rico.

Remedy

Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.

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