Potential risk of a cytotoxic substance on the exterior surface of the Carboplatin 10mg/ml vial (B071676AA)

Hospira, a Pfizer company, would like to inform healthcare professionals of the potential risk of methotrexate being present on the exterior surface of one batch of Carboplatin 10mg/ml vials. A substance on the exterior surface of a vial of Carboplatin 150mg/15mL was reported through the product complaint management program for batch B071676AA (Exp: Jun 2016). Upon investigation, the substance was determined to be Methotrexate resulting from Methotrexate vial breakage/spill during the packing process at the manufacturing site. Personnel handling product from the above batch should wear PVC gloves, safety glasses and protective clothing such as disposable gowns and masks. As the Carboplatin vials are contained within secondary packaging (cartons) and then placed within a larger cardboard box (shipper), the impact on other personnel i.e. logistic staff moving the stocks is low. Please refer to the Dear Healthcare Professional Letter (DHCPL) for more details.