# FDA recall D-1648-2012

> **Hospira Inc.** · Class III · drug recall initiated 2012-07-02.

## Product

Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS),  b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx only, Hospira, Inc., Lake Forest, IL 60045, Product of Australia

## Reason for recall

Failed PH specification:  The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1648-2012
- **Recalling firm:** Hospira Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-07-02
- **Report date:** 2012-08-22
- **Termination date:** 2017-07-24

- **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-1648-2012

## Citation

> AI Analytics. FDA recall D-1648-2012. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1648-2012. Source: US FDA. Licensed CC0.

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