# FDA recall D-135-2013

> **Genentech Inc** · Class I · drug recall initiated 2012-07-30.

## Product

Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA  94080-4990, NDC 50242-903-69; and 1 Reconstitution Instructions per kit; Investigation Use only, Genentech, Inc., 1 DNA Way, South San Francisco, CA  94080-4990.

## Reason for recall

Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-135-2013
- **Recalling firm:** Genentech Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-07-30
- **Report date:** 2013-01-30
- **Termination date:** 2013-03-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South San Francisco, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-135-2013

## Citation

> AI Analytics. FDA recall D-135-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-135-2013. Source: US FDA. Licensed CC0.

---

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