FDA issues US-wide recall of Mylan’s EpiPen

pharmafile | April 3, 2017 | News story | Medical Communications, Sales and Marketing FDA, Mylan, epipen 

After recent reports of around 80,000 defective EpiPen’s across Australia, New Zealand, Japan, Norway, Denmark, Finland and Ireland, the FDA has called for a voluntary nationwide recall of Mylan’s auto-injector in the US after news that products in that region are also failing to activate properly.  

“The expanded voluntary recall is being initiated in the US and also will extend to additional markets in Europe, Asia, North and South America,” Mylan said.

The recall concerns a small number of devices across 13 lots, which have been manufactured with defective parts which prevent them for working correctly. All those with non-working products will be offered a replacement, but must contact Mylan directly. The FDA is also requesting that anyone affected reports it to its Medwatch website. Generic versions of the product are exempt from the recall.

All EpiPen models are manufactured at a single plant in St Louis, Missouri, so it is as yet unclear what caused the defective issue in the first place, or why this new wave of ineffective models was not included in the original recall in March.

Matt Fellows

Related Content

FDA grants marketing authorisation to DNA test for predisposition to certain cancers

The US Food and Drug Administration (FDA) has granted de novo marketing authorisation to the …

Biogen’s biosimilar Tofidence approved by FDA

Biogen has announced that the US Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) …


Karuna Therapeutics submits NDA to FDA for schizophrenia treatment

Karuna Therapeutics has announced that it has submitted a New Drug Application (NDA) to the …

Latest content