# FDA recall D-154-2013

> **Hospira Inc.** · Class I · drug recall initiated 2012-11-08.

## Product

Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira, Inc., Lake Forest, IL 60045, Product of Australia.

## Reason for recall

Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-154-2013
- **Recalling firm:** Hospira Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2012-11-08
- **Report date:** 2013-02-13
- **Termination date:** 2017-03-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-154-2013

## Citation

> AI Analytics. FDA recall D-154-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-154-2013. Source: US FDA. Licensed CC0.

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