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Label Issues Prompt IV Bag Recall

Jolynn Tumolo

B Braun Medical Inc is recalling 43,812 bags containing 0.9% sodium chloride injection because of product labeling concerns. According to the August 16, 2023, US Food and Drug Administration (FDA) Enforcement Report, “the description, warnings, storage information, and instructions for use are either missing or partially printed.”

The recall affects 0.9% sodium chloride injection, 1000 mL Excel Plus container (NDC 0264-5802-00), from lot 0061852531 (Exp 2/28/25). The product was distributed throughout the United States.

B Braun Medical voluntarily initiated the recall on August 2, 2023. On August 8, 2023, the FDA designated the recall Class III. The classification suggests use of the recalled product is not likely to cause harm.

Sodium chloride injection is administered intravenously to supply water and salt to the body.

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