Update on precautionary recall of Epipen autoinjectors

News Category: Regulatory news

Date: 07/04/2017

Following the recent recall of Epipen lot 5FA665G, the HPRA wishes to advise that Mylan / Meda has voluntarily expanded the precautionary recall to include additional lots distributed in a number of countries. 

There is no evidence that, for Ireland, any lot other than 5FA665G is affected by this quality defect and we are not aware of any issues having been reported globally for these additional lots.

An expanded recall is not being initiated in Ireland at this time as there is insufficient stock to replace the lots in question. Given the absence of any reports of injection failure in the additional lots, and given that the estimated defect rate is extremely low, this is considered to be a prudent and appropriate response at this time and in the best interests of patients. 

The HPRA wishes to remind patients that, in line with current medical guidelines, it is advised that they continue to carry two pens at all times. In addition, patients should seek immediate medical attention following administration of any autoinjector. 

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