Pharmalucence, Inc. recalls Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Int
Recalled July 31, 2013 · FDA recall D-808-2013 · Pharmalucence
Hazard
Presence of Particulate Matter; particulate found in retain samples · FDA Class III
Units
17,260 vials
Sold at
Nationwide & Bahamas, Barbados, Bermuda, Japan
Description
Presence of Particulate Matter; particulate found in retain samples
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
Manufacturer(s)
Pharmalucence, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →