D-1083-2023 Class III Terminated

Recalled by B. Braun Medical Inc. — Daytona Beach, FL

FDA drug recall D-1083-2023 was initiated by B. Braun Medical Inc. on August 2, 2023 and is designated Class III. Reason for recall: Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed. The recall status is terminated (terminated July 7, 2025). Affected quantity: 43,812 bags.

Recall Details

Product Type
Drugs
Report Date
August 16, 2023
Initiation Date
August 2, 2023
Termination Date
July 7, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
43,812 bags

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.

Distribution Pattern

United States

Code Information

Lot #: 0061852531, Exp 2/28/2025