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LIDOCAINE HYDROCHLORIDE Recall D-0102-2024

Description: 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11

LIDOCAINE HYDROCHLORIDE Recall D-0102-2024 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0102-2024
Event ID93124
BrandLIDOCAINE HYDROCHLORIDE
Generic NameLIDOCAINE HYDROCHLORIDE
ManufacturerLIDOCAINE HYDROCHLORIDE
Original Package?1
Active SubstanceLIDOCAINE HYDROCHLORIDE
Drug RouteINTRAVENOUS
DistributionNationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
Quantity3,200 vials
Recall ReasonPresence of Particulate Matter: identified as glass.
Drug ClassificationClass I
Drug Code Info20231115
Product NDC0409-1323 0409-4903 0409-4904
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 IdentifierV13007Z41A
Drug Application NumberANDA040302
Structured Product Labeling (SPL ID)3a6e4402-7b97-4d62-8239-16c2ff17009d
Structured Product Labeling (SPL Set ID)ad1ef0a8-88db-4648-c098-d009eaeb4e5b
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