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Recall Observatory FDA recall evidence

Drug product

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.

D-153-2013

November 08, 2012

Class I

Product summary

Firm
Hospira Inc.
Event
Event 63548
Status
Completed
Classification
Class I
Quantity
23,315 vials
Official record key
drug-enforcement:D-153-2013

Official wording

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

Code information: Lot #: Z021650AA, Exp. 08/2013

Distribution pattern: Nationwide and Puerto Rico.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulates