# FDA recall D-219-2013

> **Pfizer Inc.** · Class III · drug recall initiated 2012-11-26.

## 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

- **Recall number:** D-219-2013
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class III
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-219-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-219-2013. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*