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Carboplatin Injection by Hospira: Recall - Visible Particulate Matter Identified

Posted Dec 15 2012 12:00am

[Posted 12/15/2012]

AUDIENCE: Pharmacy, Patient, Health Professional

ISSUE: Hospira, Inc. is further informing the general public about a previously communicated voluntary user-level recall of three lots of Carboplatin Injection due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. If particulate matter from crystallization is injected into a patient, it may potentially become lodged in and obstruct blood vessels, potentially causing local infarction, thromboembolism and vasculitis. Chronically, following sequestration, granulomatous formation in the lungs is possible.

BACKGROUND: Carboplatin Injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. Carboplatin Injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with Cisplatin.

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-877-650-8362 between the hours of 8am and 5pm EST, Monday through Friday, to arrange for the return of the product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety

Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[12/14/2012 - Firm Press Release - Hospira]

[07/13/2012 - Firm Press Release - Hospira]

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