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Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial,...

FDA Recall #D-154-2013 — Class I — November 8, 2012

Recall #D-154-2013 Date: November 8, 2012 Classification: Class I Status: Completed

Product Description

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.

Recalling Firm

Hospira Inc. — Lake Forest, IL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

31,326 vials

Distribution

Nationwide and Puerto Rico.

Code Information

lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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