FDA recall D-1747-2019

Product

ADO-TRASTUZUMAB 210 MG/250 ml NS; ADO-TRASTUZUMAB E 213 MG / 250 ML NS; ADO-TRASTUZUMAB 242 MG/250 ml NS; ADO-TRASTUZUMAB EMT 168 mg / 250 ml NS; ADO-TRASTUZUMAB E 160 MG / 250 ML NS ADO-TRASTUZUMAB 150 mg / 250 ml NS; ADO-TRASTUZUMAB EMT 301 mg / 250 ml NS; ADO-TRASTUZUMAB EMTANSINE 230mg/250ml NS IV 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-1747-2019