FDA recall D-808-2013

Pharmalucence, Inc. · Class III · drug

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

Distribution

Nationwide & Bahamas, Barbados, Bermuda, Japan

Key facts

Status: Terminated
Initiation date: 2013-05-30
Report date: 2013-07-31
Termination date: 2013-10-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-808-2013