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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1189-2022 |
| Event ID | 90455 |
| Brand | DRAXIMAGE MAA |
| Generic Name | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED |
| Manufacturer | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED |
| Original Package? | 1 |
| Active Substance | ALBUMIN AGGREGATED |
| Drug Route | INTRAVENOUS |
| Distribution | Product was distributed to retailers nationwide. |
| Quantity | 519 cartons/30 vials each |
| Recall Reason | Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing. |
| Drug Classification | Class II |
| Drug Code Info | 20220720 |
| Product NDC | 65174-270 |
| Recall Initiation Date | 20220616 |
| Report Date | 20220720 |
| Classification Date | 20220708 |
| Address | 16751 Rte Transcanadienne Kirkland, Canada |
| Recalling Firm | Jubilant Draximage Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 799C8VF17R |
| Drug Application Number | BLA017881 |
| 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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