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Organon Llc

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
41
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0552-2024Class IIIAsmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, RMay 28, 2024
D-0550-2024Class IIIAsmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, RMay 28, 2024
D-0551-2024Class IIIAsmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, RMay 28, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K950861RECONSTITUTION ACCESSOREISMay 26, 1995
K853388MONOSTICON UNI-DOTAugust 22, 1985
K842314DUOCLON COLOR-CEPTAugust 24, 1984
K841525OREIA II B-HCG PREGNANCY TEST KITJune 5, 1984
K841602ACCURATE BETA 30 PREGNANCY TEST KITMay 22, 1984
K840650B-NEOCEPT 30April 4, 1984
K832801OREIA II B-HCG, ENZYME INNUNOASSAYDecember 8, 1983
K831339NEO-PREGNOSTICON DUOCLON TUBE TESTJune 8, 1983
K831109DUOCLON SLIDE TESTJune 2, 1983
K823682BETA FFIRM TESTJanuary 7, 1983
K812967ACCURATE BETANovember 6, 1981
K812334B-NEOCEPTSeptember 1, 1981
K812261ACCURATE IAugust 31, 1981
K811940OREIA II, B-HCGAugust 3, 1981
K811941NEOCEPTJuly 27, 1981
K802974RAPI-DOTDecember 19, 1980
K802634STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.December 11, 1980
K802693OREIA-Q-TY, ENZYME IMMUNOASSAYDecember 10, 1980
K802464OREAI-Q-TU TESTOctober 31, 1980
K802358OREIA-Q-DIGOctober 10, 1980