Mylan N.V. announced that its U.S.-based Mylan Institutional business is expanding its voluntary nationwide recall to the hospital/user level of select lots of a number of injectable products due to the presence of visible foreign particulate matter observed during testing of retention samples.
Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. Intrathecal administration could result in a life threatening adverse event or result in permanent impairment of a body function. Intravenous administration has the potential to damage and/or obstruct blood vessels that could induce emboli, particularly in the lungs. If a right to left cardiac shunt is present, the particulate may lead to arterial emboli and result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function or tissue necrosis.
Other adverse effects associated with intravenous injection of particulate matter include local inflammation, phlebitis, allergic response and/or embolization in the body and infection. Intra-arterial administration could result in damage to blood vessels in the distal extremities or organs. Intramuscular administration could result in foreign-body inflammatory response, with local pain, swelling and possible long term granuloma formation.
Two chemotherapy drugs are involved. Gemcitabine for Injection, USP is an intravenously administered product indicated for the treatment of ovarian cancer, breast cancer, non-small cell lung cancer and pancreatic cancer. The lots were distributed in the U.S. between January 8, 2014, and February 10, 2015, and were manufactured and packaged by Agila Onco Therapies Limited, a Mylan company. Lot 7801084 and 7801110 are packaged with a Pfizer Injectable label.
Methotrexate Injection, USP 25 mg/mL can be administered intramuscularly, intravenously, intra-arterially, or intrathecally and is indicated for certain neoplastic diseases, severe psoriasis and adult rheumatoid arthritis. The lot was distributed in the U.S. between December 8, 2014, and December 19, 2014, and was packaged by Agila Onco Therapies Limited, a Mylan company.
See the Recall
See also Medical Law Perspectives, May 2015 Report: Chemotherapy: Risks and Liabilities When the Treatment Is Toxic
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication