Recalls / Class II

Class IID-1759-2019

Product

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

Affected lot / code info

All lots within expiry

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

Infusion Options, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

5924 13th Ave, N/A, Brooklyn, New York 11219-4934

Distribution

Quantity

N/A

Distribution pattern

NY only

Timeline

Recall initiated

2019-06-12

FDA classified

2019-08-15

Posted by FDA

2019-08-21

Terminated

2025-03-21

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1759-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.