Synthetopes Inc

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1399-2019Class IIPentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.May 28, 2019
D-1404-2019Class IISn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.May 28, 2019
D-1403-2019Class IISn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.May 28, 2019
D-1405-2019Class IISn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, SynthetMay 28, 2019
D-1401-2019Class IISn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, SyntheMay 28, 2019
D-1406-2019Class IISn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room TemperatMay 28, 2019
D-1400-2019Class IISn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.May 28, 2019
D-1402-2019Class IISulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, SyntheMay 28, 2019