Update on precautionary recall of chemotherapy products

News Category: Regulatory news

Date: 19/10/2015

The Health Products Regulatory Authority (HPRA) today provides an update on the precautionary recall of a number of chemotherapy medicines manufactured by Fannin Compounding Limited (FCL). The HPRA continues to investigate the incident at FCL which led to this recall and to liaise closely with the HSE on the matter. 

Based on the information provided by the company, the HPRA states that as of as of today (Monday 19 October) the number of potentially implicated units has reduced to 78.  This means that 219 of the original 297 units are deemed clear of risk. This figure includes recalled unused product as well as units that have now passed the incubation period of 14 days (see also below). 

The HPRA continues to stress that this is a precautionary recall and there is no evidence at this point to suggest an issue with any of the units. To-date the HPRA has not received reports of any adverse events associated with these products. Patients who have received the potentially implicated medicines have been contacted by their hospitals as a precautionary measure, informed of the situation and offered a medical appointment. 

Over the coming days, FCL will be updating each hospital in respect of the status of the specific units they received. This will enable them to confirm those patients who have received a product free from risk of contamination.  FCL has confirmed that, in the case of 3 hospitals, the units supplied are no longer implicated. These hospitals are: Naas General Hospital, Portiuncula Hospital and the Royal Victoria Eye and Ear Hospital.

Background Note: The issue with these products 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 one day and the HPRA was notified. 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 29 September were recalled.  

The issue relates only to one isolator (production equipment), no issues have been identified with other production equipment which is also subject to the same daily test. The isolator concerned has been taken out of use pending completion of the investigation.

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