FDA Drug recall D-808-2013
Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging
- FDA Drug
- Class III
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class III recall of Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging by Pharmalucence, citing presence of Particulate Matter; particulate found in retain samples.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-808-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-05-30 |
| Published | 2013-07-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmalucence |
| Distribution | US |
Product
Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821
Reason
Presence of Particulate Matter; particulate found in retain samples
Identifiers
| code_info | Lot 280011, Exp 08/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-808-2013%22
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