FDA recall D-1065-2013

Product

Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4495-22

Reason for recall

Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-09-13

Report date

2013-10-09

Termination date

2014-10-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chesterbrook, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1065-2013