Status
Terminated
Drug Enforcement D-219-2013
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Classification
Class III
Report Date
April 3, 2013
Termination Date
March 31, 2015
Product Information
- Product description
- 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
- Product quantity
- 10920 kits
- Reason for recall
- Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Pfizer Inc.
- Address
-
235 East 42nd Street
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-219-2013
- Event ID
- 64690
- Recall initiation date
- November 26, 2012
- Center classification date
- March 26, 2013
- Code info
- Lots P00025A; P00027B
- More code info
- —