FDA recall D-1771-2019

Infusion Options, Inc. · Class II · drug

Product

Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB; Doxorubicin Liposomal 66 MG/250 ML D5W, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233 Doxorubicin 16 MG/1000 ML NS IV WITH Vincristine 0.6 MG and Etoposide 78 MG Doxorubicin 16 MG/1000 ML NS IV WITH Vincristine 0.6 MG and Etoposide 78 MG Duplicate Doxorubicin 45 MG / 22.5 ML IVP SYRINGE

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-1771-2019