FDAClass IFebruary 13, 2013

Carboplatin Injection recall: Particulate Matter

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…

Why was Carboplatin Injection recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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…
Recalling firm
Hospira Inc.
Quantity
31,326 vials
Distribution
Nationwide and Puerto Rico.
Recall date
February 13, 2013
Classification
Class I
Status
Completed
Agency
FDA (drug)
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