Product Safety Recalls

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SODIUM BICARBONATE Recall D-0100-2024

Description: 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24

SODIUM BICARBONATE Recall D-0100-2024 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0100-2024
Event ID93124
BrandSODIUM BICARBONATE
Generic NameSODIUM BICARBONATE
ManufacturerSODIUM BICARBONATE
Original Package?1
Active SubstanceSODIUM BICARBONATE
Drug RouteINTRAVENOUS
DistributionNationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
Quantity24,900 vials
Recall ReasonPresence of Particulate Matter: identified as glass.
Drug ClassificationClass I
Drug Code Info20231115
Product NDC0409-5534
Recall Initiation Date20231002
Report Date20231115
Classification Date20231109
Address235 East 42nd Street
New York, NY 10017-5703
United States
Recalling FirmPfizer Inc.
Initial Notification Letter
Unique Ingredient Identifier8MDF5V39QO
Drug Application NumberANDA202679
Structured Product Labeling (SPL ID)84dd5f18-5b16-4181-87c5-fd6cf4df147c
Structured Product Labeling (SPL Set ID)85ac5491-eb50-4bd1-b5ed-c34457632311
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