FDA-Drug2013-07-31Class III
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
Pharmalucence, Inc.
Hazard
Presence of Particulate Matter; particulate found in retain samples
Sold states
Nationwide & Bahamas, Barbados, Bermuda, Japan
Affected count
17,260 vials
Manufactured in
29 Dunham Rd, N/A, Billerica, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-808-2013Don't want to check this manually?
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