Infusion Options, Inc.

FDA Regulatory Profile

Summary

Total Recalls
76
510(k) Clearances
0
Inspections
2
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-1753-2019Class IIBLEOMYCIN 18 UNITS / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11June 12, 2019
D-1793-2019Class IINIVOLUMAB 480 MG / 100 ML NS IVPB; NIVOLUMAB 200 mg / 100 ML NS IVPB; NIVOLUMAB 165 mg / 100 ML NS IJune 12, 2019
D-1759-2019Class IICisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL; Cisplatin 4June 12, 2019
D-1786-2019Class IIINJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 100 ml NS IVPB, Rx Only, Infusion Options,June 12, 2019
D-1761-2019Class IICyclophosphamide 840 MG / 250 ML NS IVPB; Cyclophosphamide 1112 MG / 250 ML NS IVPB; CyclophosphamidJune 12, 2019
D-1757-2019Class IICARFILZOMIB 65 MG IN 50 ML D5W IVPB; CARFILZOMIB 75 MG IN 50 ML D5W IVPB; CARFILZOMIB 50 MG IN 50 MLJune 12, 2019
D-1746-2019Class IIAdcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-49June 12, 2019
D-1760-2019Class IICisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL; Cisplatin 4June 12, 2019
D-1781-2019Class IIGemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; Gemcitabine 1290 MGJune 12, 2019
D-1784-2019Class IIIFOSFAMIDE 9200 MG / 1 L NS IVPB WITH MESNA 9200 MG, Rx Only, Infusion Options, Inc. 5924 13the Ave,June 12, 2019
D-1809-2019Class IIRITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL; RITUXAN 562 MG IN 562 June 12, 2019
D-1819-2019Class IIFERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, June 12, 2019
D-1813-2019Class IISOLIRIS 1200 MG QS 240 ML NACL0.9% IVPB; SOLIRIS 900 MG QS 180 ML NACL 0.9% IVPB, Rx Only, Infusion June 12, 2019
D-1747-2019Class IIADO-TRASTUZUMAB 210 MG/250 ml NS; ADO-TRASTUZUMAB E 213 MG / 250 ML NS; ADO-TRASTUZUMAB 242 MG/250 mJune 12, 2019
D-1772-2019Class IIDurvalumab 651 mg/ 250 ml NS IVPB; Durvalumab 650 mg/ 250 ml NS IVPB, Rx Only, Infusion Options, IncJune 12, 2019
D-1800-2019Class IIPACLITAXEL PROTEIN 175 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 190 MG/100 ML NS IVPB; PACLITAXEL PROTEJune 12, 2019
D-1771-2019Class IIDoxorubicin Liposomal 71 MG / 250 ML D5W IVPB; Doxorubicin Liposomal 66 MG/250 ML D5W, Rx Only, InfuJune 12, 2019
D-1773-2019Class IIENTYVIO 300 MG /250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219June 12, 2019
D-1758-2019Class IICETUXIMAB 335 MG / 167.5 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219June 12, 2019
D-1744-2019Class IIOxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusion Options, Inc. 592June 12, 2019