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

Recall Number: D-1759-2019

Firm: Infusion Options, Inc.

Classification: Class II

Status: Terminated

Report Date: 20190821

Initiation Date: 20190612

Termination Date: 20250321

Reason for Recall

Lack of Assurance of Sterility

Product Description

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