Product Safety Recalls

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SODIUM BICARBONATE Recall D-0023-2023

Description: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.

SODIUM BICARBONATE Recall D-0023-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0023-2023
Event ID90956
BrandSODIUM BICARBONATE
Generic NameSODIUM BICARBONATE
ManufacturerSODIUM BICARBONATE
Original Package?1
Active SubstanceSODIUM BICARBONATE
Drug RouteINTRAVENOUS
DistributionNationwide within the United States
Quantity148,920
Recall ReasonDefective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Drug ClassificationClass I
Drug Code Info20221102
Product NDC72572-740
Recall Initiation Date20221004
Report Date20221102
Classification Date20221027
Address1245 Blowing Rock Blvd
Lenoir, NC 28645-3618
United States
Recalling FirmExela Pharma Sciences LLC
Initial Notification Letter
Unique Ingredient Identifier8MDF5V39QO
Drug Application NumberANDA211091
Structured Product Labeling (SPL ID)a10fdfbc-94a0-49ab-b26c-de1df042bc89
Structured Product Labeling (SPL Set ID)a10fdfbc-94a0-49ab-b26c-de1df042bc89
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