# FDA recall D-0235-2015

> **Pfizer Inc.** · Class III · drug recall initiated 2014-10-10.

## Product

TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent  MADE IN ITALY; NDC 0008-1179-01.

## Reason for recall

Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0235-2015
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-10-10
- **Report date:** 2014-11-12
- **Termination date:** 2017-04-14

- **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-0235-2015

## Citation

> AI Analytics. FDA recall D-0235-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0235-2015. Source: US FDA. Licensed CC0.

---

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