Hospira recalls injectable Carboplatin due to particulates in vialsDec 17, 2012
Pharmaceutical company Hospira Inc. has issued a recall on three Lots of its Carboplatin injection drugs because vials may contain some visible particulate matter.
According to a recall statement issued through the Food and Drug Administration this week, the presence of Carboplatin crystals in some vials obtained during a routine sampling of the injectable drugs is what has prompted the recall issued in conjunction with Hospira. The company's customers were notified of this recall late last month.
The recall is necessary because injectable drugs that contain particulate matter could cause serious injuries and possibly death in some scenarios. According to the recall statement, injectable drugs containing particulate matter "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."
Carboplatin is prescribed in the treatment of ovarian carcinoma in established combination with other approved chemotherapeutic agents, the recall statement notes. It is also indicated for palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with Cisplatin.
The following Lots are included in the recall:
* Carboplatin Injection, 450 mg/45 mL, 10 mg/mL, Cytotoxic Agent, 45 mL Multi Dose Vial
* Carboplatin Injection, 600 mg/60 mL, 10 mg/mL, Cytotoxic Agent, 60 mL Multi Dose Vial
* Carboplatin Injection, 450 mg/45 mL, 10 mg/mL, Cytotoxic Agent, 45 mL Multi Dose Vial, NOVAPLUS™
Affected Lots of the drug included the recall were distributed nationwide and to Puerto Rico from March until September of this year. Hospira reports that it has not received any adverse event reports linked to these defective drugs. The company says it also has not received any other reports from customers that say they found particulate matter in any vials it already distributed.
Hospira told the FDA that it has launched an internal investigation that aims to determine the root of the problem that led to the particulate matter in the vials.