FDA recall D-1750-2019

Product

AVASTIN 630 MG / 100 ML 0.9% NACL IVPB; AVASTIN 2.5 mg/ 0.1ML Syringe; AVASTIN 587.5 MG/100 ML 0.9% NACL IVPB; AVASTIN 350 MG/100 ML 0.9% NACL IVPB; AVASTIN 325 MG / 100 ML 0.9% NACL IVPB; AVASTIN 3.75 mg/ 0.15 ML Syringe; AVASTIN 416 MG / 100 ML 0.9% NACL IVPB; AVASTIN 360 MG/100 ML 0.9% NACL IVPB; AVASTIN 250 MG / 100 ML 0.9% NACL IVPB; AVASTIN 693.125 MG/100 ML 0.9% NACL IVPB; AVASTIN 1020 MG/100 ML NS IVPB; AVASTIN 811.875 MG/100 ML 0.9% NACL IVPB; AVASTIN 1006.25 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-1750-2019