FDA recall D-1793-2019

Infusion Options, Inc. · Class II · drug

Product

NIVOLUMAB 480 MG / 100 ML NS IVPB; NIVOLUMAB 200 mg / 100 ML NS IVPB; NIVOLUMAB 165 mg / 100 ML NS IVPB; NIVOLUMAB 240 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Reason for recall

Lack of Assurance of Sterility

Distribution

NY only

Key facts

Status: Terminated
Initiation date: 2019-06-12
Report date: 2019-08-21
Termination date: 2025-03-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brooklyn, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1793-2019