# FDA recall D-1682-2012

> **Hospira Inc.** · Class II · drug recall initiated 2012-06-27.

## Product

Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; N DC 61703-342-50

## Reason for recall

The affected lots of Carboplatin Injection, Cytarabine  Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.

## Distribution

Nationwide, including Puerto Rico and Guam.    Product was also distributed internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand and  Vietnam

## Key facts

- **Recall number:** D-1682-2012
- **Recalling firm:** Hospira Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-06-27
- **Report date:** 2012-09-26
- **Termination date:** 2016-12-15

- **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-1682-2012

## Citation

> AI Analytics. FDA recall D-1682-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1682-2012. Source: US FDA. Licensed CC0.

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