0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. ...

FDA Recall #D-1083-2023 — Class III — August 2, 2023

Recall #D-1083-2023 Date: August 2, 2023 Classification: Class III Status: Terminated

Product Description

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

Reason for Recall

Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.

Recalling Firm

B. Braun Medical Inc. — Daytona Beach, FL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

43,812 bags

Distribution

United States

Code Information

Lot #: 0061852531, Exp 2/28/2025

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated