Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi… — Class III drug recall D-808-2013
Terminated recall by Pharmalucence, Inc., reported 2013-07-31, distributed nationwide. Presence of Particulate Matter; particulate found in retain samples
| Recall number | D-808-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmalucence, Inc., Billerica, MA, United States |
| Recall initiated | 2013-05-30 |
| Classified | 2013-07-19 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2013-10-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, BM, BS, JP |
| Quantity | 17,260 vials |
| Reason classes | specification failure |
| NDC | 45567-0555-01, 45567-0555-02 |
| Lot numbers | 08/13, 280011 |
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 for recall
Presence of Particulate Matter; particulate found in retain samples
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-808-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.