Sentara Infusion Services

FDA Regulatory Profile

Summary

Total Recalls
53
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0319-2023Class IITPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c) 108GM/AA, 330GM/DEX, 6December 27, 2022
D-0316-2023Class IISodium Chloride 0.9 % (a) 100ML (MAGNESIUM) (b) 69.3ML, (c) 71.4ML, (d) 77.7ML, (e) 130ML, (f) 210MLDecember 27, 2022
D-0303-2023Class IIMEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML, antibiotic, Rx Only, uDecember 27, 2022
D-0272-2023Class II0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML (b)2000ML (c) 72December 27, 2022
D-0324-2023Class IIVITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion Pharmacy Services, 535December 27, 2022
D-0307-2023Class IIMilrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS 150ML, (d) December 27, 2022
D-0294-2023Class IIGANCICLOVIR ( CYTOVENE) (a)1480MG IN NS 296ML, (b) 740 MG IN NS 336 ML, antiviral, Rx Only, use withDecember 27, 2022
D-0323-2023Class IIVANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, SentDecember 27, 2022
D-0302-2023Class IILEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infusion Pharmacy Services,December 27, 2022
D-0299-2023Class IIKYTRIL 350MCG IN 3.5ML NS SYRINGE, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 December 27, 2022
D-0304-2023Class IIMETHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx Only, Sentara Home InfusDecember 27, 2022
D-0310-2023Class IINAFCILLIN 24GM IN NS 1200ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion PharDecember 27, 2022
D-0295-2023Class IIHYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, Rx Only, Sentara Home InDecember 27, 2022
D-0320-2023Class IITPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c) TPN AA: 10December 27, 2022
D-0273-2023Class IIAmikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy Services, December 27, 2022
D-0278-2023Class IICEFAZOLIN (a) 12GM IN NS 600ML, (b) 2GM IN NS 100ML, (c) 2GM/20ML SW SYRINGE, (d) 3GM IN NS 150ML, aDecember 27, 2022
D-0285-2023Class IID5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, Hydration, Sentara Home Infusion Pharmacy Services, 535 IndDecember 27, 2022
D-0290-2023Class IIDOBUTAMINE, (a) 1080MG IN D5W 270ML, (b) 760MG IN D5W 190ML, ionotrop, used with a home pump, Rx onlDecember 27, 2022
D-0301-2023Class IILevaquin 750MG IN D5W 150ML, antibiotic, Rx Only, use with home pump, Sentara Home Infusion PharmacyDecember 27, 2022
D-0289-2023Class IIDiphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Home Infusion Pharmacy SerDecember 27, 2022