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Recall Observatory FDA recall evidence

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

D-1083-2023

August 02, 2023

Class III

Product summary

Firm
B. Braun Medical Inc.
Event
Event 92797
Status
Terminated
Classification
Class III
Quantity
43,812 bags
Official record key
drug-enforcement:D-1083-2023

Official wording

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

Code information: Lot #: 0061852531, Exp 2/28/2025

Distribution pattern: United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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