Carboplatin Injection Recall Issued By Hospira Due to Particulate Matter

Three lots of Carboplatin injections distributed by Hospira Inc. have been recalled due to the formation of crystals, which could pose a serious and potentially life-threatening risk for patients. 

The Hospira Carboplatin recall was announced by the FDA and Hospira last week, after an inspection found visible particulate matter in vials of the medication.

The particulate matter was identified as Carboplatin crystals, and Hospira warns that they could be deadly. The company’s customers were first notified of the problem in November.

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If injected into a patient, the Carboplatin crystals could become lodged in blood vessels, blocking them and potentially causing a heart attack, thromboembolism, and vasculitis. They could also lead to the formation of granules in the lungs. No injuries or illnesses have been linked to the Carboplatin recall.

The recall includes three lots of Carboplatin Injection Multi Dose Vials , including:

  • Carboplatin Injection, 450 mg/45 mL, 10 mg/mL, Cytotoxic Agent, 45 mL Multi Dose Vials, with lot number Z011711AA and NDC Number 61703-339-50
  • Carboplatin Injection, 600 mg/60 mL, 10 mg/mL, Cytotoxic Agent, 60 mL Multi Dose Vial, with lot number Z021650AA and NDC Number 61703-339-56
  • Carboplatin Injection, 450 mg/45 mL, 10 mg/mL, Cytotoxic Agent, 45 mL Multi Dose Vial, NOVAPLUS, with lot number Z011711AB and NDC Number 61703-360-50

All of the recalled vials have an expiration date of August 2013 and were distributed nationwide in the U.S. as well as Puerto Rico between the dates of March 2012 and September 2012.

Carboplatin injections are used for the initial treatment of advanced ovarian carcinoma in combination with other chemotherapy drugs. The medication is also approved for palliative treatment of patients with ovarian cancer that came back after chemotherapy, including patients who have been previously treated with Cisplatin.

The FDA and Hospira recommend that health care professionals stop using the recalled drugs immediately. Anyone with existing inventory should quarantine the product immediately and call Stericycle at 1-877-650-8362 to arrange to have the drugs replaced from unaffected lots.


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