Product Safety Recalls

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HEPARIN SODIUM Recall D-0097-2023

Description: Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,

HEPARIN SODIUM Recall D-0097-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0097-2023
Event ID91379
BrandHEPARIN SODIUM
Generic NameHEPARIN SODIUM
ManufacturerHEPARIN SODIUM
Original Package?1
Active SubstanceHEPARIN SODIUM
Drug RouteINTRAVENOUS
DistributionNationwide in the USA.
Quantity62,088 bags
Recall ReasonLack of assurance of sterility: Bags have the potential to leak.
Drug ClassificationClass II
Drug Code Info20230111
Product NDC0409-7620
Recall Initiation Date20221229
Report Date20230111
Classification Date20230105
Address235 East 42nd Street
New York, NY 10017-5703
United States
Recalling FirmPfizer Inc.
Initial Notification Letter
Unique Ingredient IdentifierZZ45AB24CA
Drug Application NumberNDA018916
Structured Product Labeling (SPL ID)9efb32ae-3ffe-4a82-8719-43762f675d8d
Structured Product Labeling (SPL Set ID)32e34077-aff1-4ec7-f9b0-b8e240768fb8
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