December 17, 2012
Hospira initiated a voluntary recall of 3 lots of carboplatin injection. The affected products contain visible particles, which have been identified as carboplatin crystals. Hospira is investigating further to determine and correct the cause of the crystals. The affected products were distributed in the US and Puerto Rico between March and September 2012. In the US, the following products are affected:
- Carboplatin 10 mg/mL injection, 450 mg/45 mL multidose vial (NDC 61703-339-50): lot number Z011711AA (expiry August 2013)
- Carboplatin 10 mg/mL injection, 450 mg/45 mL multidose vial, Novaplus label (NDC 61703-360-50): lot number Z011711AB (expiry August 2013)
- Carboplatin 10 mg/mL injection, 600 mg/60 mL multidose vial (NDC 61703-339-56): lot number Z021650AA (expiry August 2013)
Currently, no adverse events have been reported due to the defect. However, the particles could cause harm if injected into the patient. Potential adverse effects include local infarction, thromboembolism, or vasculitis of blood vessels; or granulomatous formation in the lungs.
Immediately stop using and quarantine any affected product. Return affected product by calling Stericycle at 1-877-650-8362 Monday through Friday, from 8AM to 5PM Eastern Standard Time. Report any adverse events to FDA online at www.fda.gov/MedWatch/report.htm, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mailing the completed form. The MedWatch form is available at http://www.fda.gov/downloads/Safety/MedWatch/DownloadForms/UCM082725.pdf.
Additional information is available at the following links:
- MedWatch Alert:
- Company Press Release:
December 17, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.