Two machines out of service in firm hit by chemo scare
Two machines which produce medicines, including cancer treatments, remain out of use at the plant at the centre of the recent scare over potentially contaminated chemotherapy products.
The medicines watchdog, the Health Products Regulatory Authority (HPRA), said its inspectors remain on site at Fannin Compounding Ltd in Dublin overseeing the recall of potentially contaminated chemotherapy medicines which were given to 200 patients.
The watchdog said that the production of critical and essential medicines at Fannin was continuing at this time, but at a reduced capacity.
"The HPRA has made relevant sectors of the health service aware of this situation," said a spokeswoman.
Bacteria which could be life-threatening was found on one of the machines, known as an isolator, and was at risk of contaminating the chemotherapy medicines. A spokeswoman for the regulator said inspectors were also continuing to investigate and evaluate the manufacturer's processes.
The recall of chemotherapy medicines which were mixed at the plant relates to one isolator machine which is now out of service. The HPRA said another isolator was also out of service following a precautionary recall of other therapies in September.
"The HPRA has requested that these two isolators not go back into use until it has reviewed the results of tests. There are a number of other isolators not in use for operational and commercial reasons," the spokeswoman said.
She said Fannin was currently producing critical and essential medicines, including chemotherapy products for cancer treatment.
"These medicines are manufactured on an individual basis following requests from hospitals for specific patients in their care," she said.
"The company took the isolator out of service as part of its procedure following the detection of cloudiness in a simulated test product. The HPRA was informed of this action on the same day."
The recent contamination on the isolator was discovered on Monday, October 12, and an alert was sent by the company to all the hospitals it supplies. However, patients were not informed for several days in many cases.
There has been no evidence that any chemotherapy products were contaminated. The HPRA said that the number of potentially implicated units had reduced to 15.
"This means that 282 of the original 297 units manufactured in the two-week period are deemed clear of risk," the spokeswoman said.
This figure includes recalled, unused product as well as units that have now passed the incubation period of 14 days for the test product.
Meanwhile, the Competition and Consumer Protection Commission has cleared the proposed acquisition of Fannin by Baxter Healthcare. Baxter agreed earlier in the summer to buy Fannin, which is part of the Irish group DCC.