Fannin Compounding in Dublin, Ireland identified a “sterility assurance issue” with one of the chemotherapy isolators used in manufacturing the drugs during routine tests. The company said it is investigating the problem and has taken the isolator out of use.
The recall affects a number of batches of unnamed chemotherapy pharmaceuticals produced at the site between September 29th and October 12th, 2015.
Fannin informed the Irish Health Service Executive (HSE), which is liaising with the Health Product Recall Authority (HPRA), the body which oversees recalls.
HSE said the company had not indicated that any drugs had been affected by the sterility scare. But all patients who received the medicines – approximately 200 – have been contacted by their treating hospitals and offered appointments with doctors to discuss their concerns.
“However, if in the interim, any of these patients experience any unexpected symptoms differing from what they normally experience after treatment, they are being advised to attend at or/and contact their treating hospital,” the organisation said.
HSE apologised “to our patients for any anxiety they may experience as a result of this issue.”
Fannin Compounding added, “We regret any upset to patients in relation to this precautionary recall.” The company was founded in 2005 in Sandyford, Dublin and performs GMP aseptic manufacturing for patients in the Republic of Ireland and Northern Ireland.