Product Safety Recalls

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AZACITIDINE Recall D-1334-2022

Description: Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56

AZACITIDINE Recall D-1334-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1334-2022
Event ID90594
BrandAZACITIDINE
Generic NameAZACITIDINE
ManufacturerAZACITIDINE
Original Package?1
Active SubstanceAZACITIDINE
Drug RouteINTRAVENOUS
DistributionDistributed in Ohio
Quantity4162 cartons
Recall ReasonSubpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Drug ClassificationClass III
Drug Code Info20220817
Product NDC68001-313
Product NUIN0000000233 N0000175595
Drug UPC0368001313568
Pharma Class (EPC)Nucleoside Metabolic Inhibitor [EPC]
Recall Initiation Date20220722
Report Date20220817
Classification Date20220811
Address400 Interpace Pkwy Bldg A
Parsippany, NJ 07054-1120
United States
Recalling FirmTeva Pharmaceuticals USA Inc
Initial Notification Letter
Unique Ingredient IdentifierM801H13NRU
Drug Application NumberNDA208216
Structured Product Labeling (SPL ID)e56bd41d-d454-2fd3-e053-2a95a90aa361
Structured Product Labeling (SPL Set ID)5f0f9ee3-a5b1-4a25-a34c-7f38c8433f4a
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