FDA-Drug2019-08-21Class II

Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL; Cisplatin 44 MG QS 500 ml NS IVPB; Cisplatin 40 MG / 500 ml 0.9% NACL; Cisplatin 36 MG / 500 ML NS IVPB; Cisplatin 73 MG QS 500 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 70 MG / 500 ml NS WITH Magnesium 1 G and Mannitol 12.5 G; Cisplatin 60 MG /250 ml 0.9% NACL Cisplatin 47 MG /250 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 150 MG / 250 ml 0.9% NACL; Cisplatin 115 MG /250 ml NS IVPB; Cisplatin 80 MG QS

Infusion Options, Inc.
Hazard

Lack of Assurance of Sterility

Sold states
NY only
Affected count
N/A
Manufactured in
5924 13th Ave, N/A, Brooklyn, NY, United States
Products
Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL; Cisplatin 44 MG QS 500 ml NS IVPB; Cisplatin 40 MG / 500 ml 0.9% NACL; Cisplatin 36 MG / 500 ML NS IVPB; Cisplatin 73 MG QS 500 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 70 MG / 500 ml NS WITH Magnesium 1 G and Mannitol 12.5 G; Cisplatin 60 MG /250 ml 0.9% NACL Cisplatin 47 MG /250 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 150 MG / 250 ml 0.9% NACL; Cisplatin 115 MG /250 ml NS IVPB; Cisplatin 80 MG QS 500 ml NS IVPB WITH Mannitol 12.5 G; Cisplatin 120 MG / 500 ML NS IVPB Cisplatin 157 MG /250 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 43 MG QS 1000 ml 0.9% NACL WITH Mannitol 12.5 G, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1760-2019

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