US Drug Recall Register
Class III · Low risk Terminated Initiated May 30, 2013 (13 years ago)

Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Presence of Particulate Matter; particulate found in retain samples

What was recalled

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

Recalling firm
Pharmalucence, Inc.
NDC code
45567-0555-1
Origin
MA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-808-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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