FDA recall D-219-2013

Product

TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL injection and 1 vial DILUENT for TORISEL, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA --- NDC 0008-1179-01

Reason for recall

Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-11-26

Report date

2013-04-03

Termination date

2015-03-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-219-2013