Urgent recall of steroid tablets

7/19/06

A prescription-only steroid medicine has been urgently recalled by the Irish Medicines Board (IMB), after it was found to be contaminated with a mould.

Patients who were dispensed with Prednisolone Tablets BP 20mg between June 30 and July 18 of this year, are being asked to return the drugs to their pharmacist or doctor.

Prednisolone is authorised in Ireland for a number of conditions. According to the IMB, the drug's manufacturer, Clonmel Healthcare, had identified problems with one particular batch. This problem was related to 'a microbial contamination issue'.

"The microbial contaminant has been identified as a mould. Moulds are often not pathogenic, i.e. not disease causing. However mould contamination in Prednisolone Tablets BP 20mg may increase the risk of infection in treated patients, because such patients may be immuno-suppressed and therefore may be more susceptible to infection from micro-organisms, such as moulds", the IMB said.

Details of the affected batch are as follows:

Product name: Prednisolone Tablets BP 20mg

Batch: 0658R

Expiry date: 06/2008

Manufacturer: Clonmel Healthcare

The IMB is requesting all patients who were dispensed with Prednisolone Tablets BP between June 30 and July 18 to do the following as soon as possible:

-Check the label to see if they are 20mg strength.

-If they are 20mg strength, do not take any more of these tablets. Instead return then to your pharmacist or doctor for further evaluation and advice.

-Tell your doctor or pharmacist that you are returning your medicine because of this issue.

Your pharmacist will be able to dispense alternative Prednisolone tablets. In the meantime, the IMB is investigating the cause of this contamination with Clonmel Healthcare.