FDA Drug recall D-1189-2022
Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufa…
- FDA Drug
- Class II
- terminated
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufa… by Jubilant Draximage, citing lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1189-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-16 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jubilant Draximage |
| Distribution | US |
Product
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.
Reason
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Identifiers
| ndc | 65174-270-30 |
|---|---|
| code_info | Lot # 1H005, exp. date Nov 30, 2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1189-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.