The discovery of the unknown particle during the testing of retention samples has led Mylan to issue a voluntary recall of eight lots of four sterile injectable products, manufactured by Agila Onco Therapies which the generics firm acquired in 2013 from Strides Arcolab for $1.6bn (€1.5bn).
The products are four lots of Gemcitabine, one of Carboplatin and one of Cytarabine – all three of which are chemotherapy treatments – as well as one lot of the rheumatoid arthritis treatment Methotrexate. Three of the affected lots are packaged with a Pfizer Injectables label.
The recall is precautionary as Mylan has not received any reports of adverse events, but the company does warn the administration of a sterile injectable that has foreign particulates could have severe consequence.
Mylan acquired eight US FDA-approved sterile manufacturing facilities through the Agila deal, and at least one lot of the affected injectable – the Cytarabine lot with a Pfizer label – was manufactured at the site in Bangalore, India, which was hit by a warning letter in September 2013.
The FDA slammed the facility after a team of inspectors discovered the use of “flaking” and non-sterile gloves in its aseptic processing suites, as well as finding crushed insects on cardboard boxes used to ship and store those gloves.
The facility is yet to have received a close-out letter but according to Mylan’s 2014 annual report, the firm continues “to work closely with the FDA to fully address its observations with respect to this facility and are working to resolve this matter expeditiously.”
Last week, Mylan found itself on the end of an unsolicited $40bn bid by fellow generics company Teva. Meanwhile, Mylan is also attempting to acquire Perrigo and made a second offer of $33bn for the firm after its first offer was rebuffed.