Pharmacia & Upjohn LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Known Names

pharmacia and upjohn company, pharmacia and upjohn, pharmacia and upjohn s.a. de c.v, pharmacia and upjohn pty limited, pharmacia and upjohn co

Recent Recalls

NumberClassProductDate
D-609-2013Class IICleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mJune 4, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K003414VARELISA TG (THYROGLOBULIN) ANTIBODIES,November 27, 2000
K002556CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1October 31, 2000
K000312VARELISA SM ANTIBODIESMarch 17, 2000
K000132ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I7February 18, 2000
K993585VARELISA TPO ANTIBODIES, MODEL 12348/12396January 5, 2000
K993388ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, FDecember 1, 1999
K993589VARELISA RNP ANTIBODIESNovember 26, 1999
K993108VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96November 12, 1999
K993109VARELISA RECOMBI ANA PROFILENovember 12, 1999
K991945PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01July 28, 1999
K991048ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, May 14, 1999
K982701UNICAP GLIADIN IGG ASSAYOctober 22, 1998
K982533UNICAP GLIADIN IGA ASSAYOctober 22, 1998
K982343ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, FSeptember 15, 1998
K981559UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAYJuly 7, 1998
K981930UNICAP THYROID PEROXIDASE IGGJuly 7, 1998
K974580ALLERGEN IMMUNOCAP F256,F245,F207,F202February 9, 1998
K962976PHARMACIA CAP SYSTEM RAST FEIADecember 23, 1996