DepoCyte is a prolonged release liposomal suspension containing cytarabine for the intrathecal treatment of lymphomatous meningitis.
The inspection was conducted by UK and French regulators at the company’s manufacturing plant in San Diego, US.
EMA said by following precautionary measures the sterility of DepoCyte can be decreased and can help protect patients from potentially harmful effects, while they also allow continued access to treatment for patients who have no suitable alternatives.
Following the precautionary measures, the Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that DepoCyte should be recalled from all EU countries where suitable alternative treatments are available.
Potential alternatives include non-liposomal cytarabine, methotrexate or thiotepa, which are approved for the treatment of lymphomatous meningitis.
The company said it has started work on a remediation plan to address the problems, one part of which involves renovation of the facility by DPR Construction which it initially hired to increase capacity in May.