Product Safety Recalls

Product Recall Tracker

IDARUBICIN HYDROCHLORIDE Recall D-0765-2022

Description: IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL), 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.

IDARUBICIN HYDROCHLORIDE Recall D-0765-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0765-2022
Event ID89876
BrandIDARUBICIN HYDROCHLORIDE
Generic NameIDARUBICIN HYDROCHLORIDE
ManufacturerIDARUBICIN HYDROCHLORIDE
Original Package?1
Active SubstanceIDARUBICIN HYDROCHLORIDE
Drug RouteINTRAVENOUS
DistributionNationwide within the United States
Quantity1565 vials
Recall ReasonPresence of Particulate Matter: Product was found to contain silica and iron oxide
Drug ClassificationClass I
Drug Code Info20220420
Product NDC0703-4154 0703-4155 0703-4156
Recall Initiation Date20220329
Report Date20220420
Classification Date20220411
Address400 Interpace Pkwy Bldg A
Parsippany, NJ 07054-1120
United States
Recalling FirmTeva Pharmaceuticals USA Inc
Initial Notification Letter
Unique Ingredient Identifier5VV3MDU5IE
Drug Application NumberANDA065036
Structured Product Labeling (SPL ID)50496107-74f2-4f7f-9654-0462d555e282
Structured Product Labeling (SPL Set ID)d521b65f-3fd2-4efe-8cab-b444921dd223
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.