Drug recall
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor…
FDA recall event 82397 · Class II · Iso-Tex Diagnostics, Inc
Key facts
| Event ID | 82397 |
|---|---|
| Recall numbers | D-1008-2019 |
| Recalling firm | Iso-Tex Diagnostics, Inc |
| Product type | Drugs |
| Products | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured. |
| Initiation date | Mar 11, 2019 |
| Report date | Mar 27, 2019 |
| Termination date | Dec 15, 2020 |
| City | Alvin |
| State | TX |
| Country | United States |
| FEI number | 1626310 |
At a glance
- 1–9 Products in this recall
- 10–99 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: