Pharmalucence, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1040-2018Class IIKit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count boJune 6, 2018
D-0815-2018Class IIKit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 April 10, 2018
D-808-2013Class IIIPharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and BreMay 30, 2013