FDA recall D-1083-2023

B. Braun Medical Inc. · Class III · drug

Product

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

United States

Key facts

Status
Terminated
Initiation date
2023-08-02
Report date
2023-08-16
Termination date
2025-07-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Daytona Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1083-2023