News Category: Regulatory news
The Health Products Regulatory Authority (HPRA) today states that a precautionary recall of a number of chemotherapy medicines has been undertaken in Ireland.
The HPRA advises that, whilst there is no evidence at this point to suggest an issue with any of the medicines recalled, the patients who have received the potentially implicated products have been contacted by their hospitals as a precautionary measure, informed of the situation and offered a medical appointment.
The implicated products, manufactured by Fannin Compounding Limited (FCL), are mainly patient specific therapies produced to order for both public and private hospitals.
The HPRA states that an issue was identified by the manufacturer when carrying out its daily assessments of the manufacturing process using a test product. This test product contains a substance which is used to aid in the detection of the potential presence of contamination. This test product is not a medicine and is not given to patients. On Monday 12 October a contamination was noted with the test product for a day on which 37 units of medicine were filled and, of which, 15 have been recovered unused during the recall. A contaminated test product does not automatically mean that the medicines produced are affected.
The test product, which is produced daily, must be incubated for 14 days to identify any contamination and, therefore, as a precaution all units manufactured from the 29th September were recalled. As of today, (16 October) the 14 day incubation period for the test products produced up to 2 October has been completed successfully and no contamination has been found. This means that 132 of a total of 297 units filled over the 14 day period are not implicated. Additionally, 45 unused units have been recovered.
The contaminant in the single unit of test product has been identified and this information has been communicated to the hospitals concerned so that prescribers can choose the best treatment in the event of any patient presenting with infection.
The HPRA is overseeing the recall and is continuing to investigate this incident and evaluate the manufacturer’s onsite processes. The equipment used in the manufacture of these products has been taken out of use pending completion of the investigation.
Note: The issue relates only to one isolator (production equipment), no issues have been identified with other production equipment which are also subject to the same daily test.