FDA recall D-1752-2019

Product

BEVACIZUMAB 784 MG / 100 ML NS IVPB; BEVACIZUMAB 350 MG/100 ml NS IVPB; BEVACIZUMAB 425 MG/ 100 ml NS IVPB; BEVACIZUMAB 420 MG/100 ml 0.9% NACL IVPB; BEVACIZUMAB 556 mg/100 ml NS IVPB BEVACIZUMAB 330 MG / 100 ML NS IVPB; BEVACIZUMAB 790 MG / 100 ML NS IVPB; BEVACIZUMAB 470 MG / 100 ML NS IVPB; BEVACIZUMAB 758 MG / 100 ML NS IVPB; BEVACIZUMAB 690 MG / 100 ML NS IVPB BEVACIZUMAB 599 MG/100 ml NS IVPB; BEVACIZUMAB 1113 MG / 100 ML NS IVPB; BEVACIZUMAB 660 MG /100 ml NS IVPB; BEVACIZUMAB 590 MG / 100 ML NS IVPB; BEVACIZUMAB 620 MG / 100 ML NS IVPB BEVACIZUMAB 800 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-1752-2019