US pharma giant Mylan is extending recall of two drugs manufactured at Bangalore plant of Agila Onco Therapies Ltd.
Mylan had acquired Agila, a sterile injectables business from Strides Arcolab in $1.75 billion deal in 2013.
The US Food and Drug Administration (FDA) said Mylan was expanding its nationwide voluntary recall to the hospital/user level of select lots of gemcitabine and methotrexate injection due to the presence of visible foreign particulate matter observed during testing of retention samples.
Mylan, in a press release on FDA website, said it is recalling seven lots of intravenously administered cancer drug gemcitabine injection in different dosages indicated for the treatment of ovarian cancer, breast cancer, non-small cell lung and pancreatic cancer.
"These lots were distributed in the US between January 2014 and February 2015, and were manufactured and packaged by Agila Onco Therapies. Lot 7801084 and 7801110 are packaged with a Pfizer injectable label," it said.
Similarly, methotrexate injection, USP 25 mg/ml has also been recalled. The drug 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 US between December 8 and 19, 2014.
Mylan in its release said 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 which 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," it said.
Other adverse effects associated with intravenous injection of particulate matter include local inflammation, phlebitis, allergic response and/or embolisation 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.
The company also said it is notifying its distributors and customers by letter and is arranging for return of all recalled products.
"Distributors, retailers, hospitals, clinics, and physicians that have these products which are being recalled should stop use and return to place of purchase," the release said.
In an earlier recall initiated in April, Mylan recalled one lot of the cancer drug carboplatin with a Mylan label. The drug is an intravenously administered product indicated for treatment of advanced ovarian carcinoma. The company has also recalled seven lots of cancer drugs with Pfizer labels. This includes five lots of gemcitabine in different dosages, and one lot each of methotrexate injection and cytarabine injection.
Cytarabine can be administered intravenously or intrathecally and in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients.
