Product Safety Recalls

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EPINEPHRINE BITARTRATE Recall D-1053-2022

Description: Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MFG: Fresenius Kabi USA LLC, NDC 63323-483-27

EPINEPHRINE BITARTRATE Recall D-1053-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1053-2022
Event ID89646
BrandXYLOCAINE
Generic NameLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
ManufacturerLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
Original Package?1
Active SubstanceEPINEPHRINE BITARTRATE LIDOCAINE HYDROCHLORIDE ANHYDROUS
Drug RouteINFILTRATION
DistributionUSA nationwide.
Quantity33 trays/25 vials per tray
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC63323-481 63323-492 63323-491
Drug UPC0363323484576 0363323485016 0363323483036
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient Identifier30Q7KI53AK EC2CNF7XFP
Drug Application NumberNDA006488
Structured Product Labeling (SPL ID)ea480a68-5927-4278-9deb-2956961da428
Structured Product Labeling (SPL Set ID)ba082c2f-64f4-419d-9c88-74f203316e17
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