FDA recall D-1758-2019

Infusion Options, Inc. · Class II · drug

Product

CETUXIMAB 335 MG / 167.5 ML 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-1758-2019