Drug recall
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL, Rx only, Manufactured by Jubilant DraxImage, Inc…
FDA recall event 73586 · Class III · Jubilant Draximage Inc
Key facts
| Event ID | 73586 |
|---|---|
| Recall numbers | D-0812-2016 |
| Recalling firm | Jubilant Draximage Inc |
| Product type | Drugs |
| Products | SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Label Error on Declared Strength |
| Initiation date | Mar 11, 2016 |
| Report date | Apr 13, 2016 |
| Termination date | Aug 7, 2017 |
| 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: