ENS Event | |
|---|---|
07:00 Jan 21, 2013 | |
| Title | Agreement State Report- Pharmaceutical Distribution Failed Quality Control Testing |
| Event Description | The following information was received by email:
This First Notice constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received WITHOUT verification or evaluation, and is basically all that is known by the [Arizona Radiation Regulatory] Agency Staff at this time. At approximately 0830 [MST on 1/22/13], the Agency was notified by PCI [Patient Care Infusion], the Licensee, that yesterday [1/21/13] they distributed a pharmaceutical that failed the quality control testing. Several licensees reported to them they were receiving improper data from patients injected with the material. A total of 9 licensees were shipped the radiopharmaceutical and the licensee estimates as many as 13 patients may have received the deficient material. Additionally, a like number were scheduled to receive the material but did not receive the material. The Licensee is preparing the 30 day written report of this event. The Agency continues to investigate this event. Arizona First Notice: 13-003 |
| Where | |
|---|---|
| Patient Care Infusion, Llc Tempe, Arizona (NRC Region 4) | |
| License number: | AZ-7-572 |
| Organization: | Arizona Radiation Regulatory Agency |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+30.17 h1.257 days <br />0.18 weeks <br />0.0413 months <br />) | |
| Opened: | Aubrey Godwin 13:10 Jan 22, 2013 |
| NRC Officer: | Vince Klco |
| Last Updated: | Jan 22, 2013 |
| 48691 - NRC Website | |
Patient Care Infusion, Llc with Agreement State | |
WEEKMONTHYEARENS 486912013-01-21T07:00:00021 January 2013 07:00:00
[Table view]Agreement State Agreement State Report- Pharmaceutical Distribution Failed Quality Control Testing 2013-01-21T07:00:00 | |