FDA recall D-1787-2019

Product

IRINOTECAN 250 MG /500 ml D5W IVPB; IRINOTECAN 110 MG /250 ML D5W IVPB; IIRINOTECAN 250 MG/250 ML NS IVPB; IRINOTECAN 315 MG / 250 ML NS IVPB; IRINOTECAN 155 MG / 500 ml D5W IVPB; IRINOTECAN 75 MG / 250 ML NS IVPB; IRINOTECAN 140 MG / 250 ML NS IVPB; IRINOTECAN 317 MG /500 ML D5W IVPB; IRINOTECAN 135 mg / 500 ml D5W IVPB; IRINOTECAN 265 MG / 500 ML D5W IVPB; IRINOTECAN 140 MG / 500 ml D5W IVPB; IRINOTECAN 195 mg / 500 ml D5W IVPB; IRINOTECAN 245 mg / 500 ml D5W IVPB; IRINOTECAN 130 MG / 500 ML D5W 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-1787-2019