Mylan announces nationwide EpiPen recall over potential defect

Mylan's new generic EpiPen is not part of the voluntary recall and has been deemed a suitable replacement for the potentially defective product.

Issue Pfizer Canada, in consultation with Health Canada, is voluntarily recalling one lot of EpiPen auto-injector and one lot of EpiPen Jr. auto-injector.

Mylan said both reported failures included devices, manufactured between December 2015 and July 2016, that were already included in the original recall.

EpiPens deliver an emergency dose of adrenaline to people at risk of a serious allergic reaction. EpiPens are used to treat severe allergic reactions.

Mylan's business practices came under intense scrutiny past year after consumers started to notice that the price of the EpiPen was rising at a rapid rate.

Consumers who have EpiPens made other than those dates do not need to replace it before its expiration. The Jr Auto-Injector expires in March 2017 and lot number 5GR765. Mylan brands adult versions with a yellow label and junior devices with a green label.

There is a potential defect with a part in the injector making it hard to activate in an emergency, which could mean significant risks for people experiencing a life-threatening allergic reaction.

The company said more than 100,000 products that could be affected were distributed in Canada. Furthermore, all patients should take comfort in knowing that the whole of this recall is being conducted with full and open supervision of the United States Food and Drug Administration. The company is, however, advising that due to the nature of the need, those seeking to replace their potentially faulty auto-injector devices should still keep them handy, even if they can not get a replacement.

  • Wendy Palmer