Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial,...
FDA Recall #D-153-2013 — Class I — November 8, 2012
Product Description
Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56.
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
23,315 vials
Distribution
Nationwide and Puerto Rico.
Code Information
Lot #: Z021650AA, Exp. 08/2013
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated