Product Safety Recalls

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SODIUM CHLORIDE Recall D-0347-2023

Description: 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10

SODIUM CHLORIDE Recall D-0347-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0347-2023
Event ID91658
BrandSODIUM CHLORIDE
Generic NameSODIUM CHLORIDE
ManufacturerSODIUM CHLORIDE
Original Package?1
Active SubstanceSODIUM CHLORIDE
Drug RouteINTRAVENOUS
DistributionUSA Nationwide.
Quantity483,229 bags
Recall ReasonLack of sterility assurance: leaking bags.
Drug ClassificationClass II
Drug Code Info20230301
Product NDC0264-5802 0264-5804
Recall Initiation Date20230210
Report Date20230301
Classification Date20230223
Address1845 Mason Ave
Daytona Beach, FL 32117-5102
United States
Recalling FirmB. Braun Medical Inc.
Initial Notification Letter
Unique Ingredient Identifier451W47IQ8X
Drug Application NumberNDA019635
Structured Product Labeling (SPL ID)d34ea9bc-a1f9-402a-97cf-894505cee75d
Structured Product Labeling (SPL Set ID)e44c41ae-c9c8-4dd8-ba6c-cebb585378aa
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