Product Safety Recalls

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ALBUMIN AGGREGATED Recall D-1189-2022

Description: Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufactured for Jubilant Draximage Inc. Kirkland, Canada, NDC 65174-270-30.

ALBUMIN AGGREGATED Recall D-1189-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1189-2022
Event ID90455
BrandDRAXIMAGE MAA
Generic NameKIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED
ManufacturerKIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED
Original Package?1
Active SubstanceALBUMIN AGGREGATED
Drug RouteINTRAVENOUS
DistributionProduct was distributed to retailers nationwide.
Quantity519 cartons/30 vials each
Recall ReasonLack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Drug ClassificationClass II
Drug Code Info20220720
Product NDC65174-270
Recall Initiation Date20220616
Report Date20220720
Classification Date20220708
Address16751 Rte Transcanadienne
Kirkland,  
Canada
Recalling FirmJubilant Draximage Inc
Initial Notification Letter
Unique Ingredient Identifier799C8VF17R
Drug Application NumberBLA017881
Structured Product Labeling (SPL ID)306135d6-d184-47dd-a2a3-6adfa03a8699
Structured Product Labeling (SPL Set ID)bbefaa05-1dc0-3ae7-7264-ce1eddf0da2b
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