Completion of precautionary recall action for chemotherapy medicines

News Category: Regulatory news

Date: 23/10/2015

The HPRA today confirms the completion of the precautionary recall action for a number of chemotherapy medicines manufactured by Fannin Compounding Limited (FCL).

Based on the information provided by the company, the number of potentially implicated units has reduced to eight. This means that 289 of the original 297 units manufactured in the two week period covered by the precautionary recall are deemed clear of risk. This figure includes recalled unused medicine as well as units that have now passed the incubation period of 14 days for the test product (see below).

This recall arose when a test product, which is not a medicine and is not administered to patients, showed a contamination some four days after production on 8 October 2015. Chemotherapy medicine, manufactured on the same day as that test product, was the subject of a precautionary recall, along with all other medicine compounded within a 14 day window (where the daily test product had not completed a 14-day incubation period).

A maximum of eight patients received chemotherapy medicine compounded on 8 October. It is important to stress that evidence of contamination in the test product is not evidence of contamination of the chemotherapy medicines as the test product contains substances that are different to those in the medicine. As was the case with all the potentially implicated chemotherapy medicines, the hospitals in receipt of these units were informed and the patients who received the potentially implicated medicines were contacted by their hospitals as a precautionary measure, informed of the situation and offered a medical appointment. The HPRA has not received reports of any adverse events associated with these medicines.

While the recall action for the chemotherapy medicines has been completed, the HPRA continues to investigate the incident at FCL which led to this recall and to liaise closely with the HSE on the matter.

Further information from the HPRA:

Precautionary recall of chemotherapy products manufactured by Fannin Compounding Limited

Update on precautionary recall of chemotherapy products (19/10/15)

Additional update on precautionary recall of chemotherapy products (21/10/15)

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