Drug recall
Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass…
FDA recall event 90455 · Class II · Jubilant Draximage Inc
Key facts
| Event ID | 90455 |
|---|---|
| Recall numbers | D-1189-2022 |
| Recalling firm | Jubilant Draximage Inc |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing. |
| Initiation date | Jun 16, 2022 |
| Report date | Jul 20, 2022 |
| Termination date | Jul 25, 2023 |
| City | Kirkland |
| Country | Canada |
| FEI number | 3009003838 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: