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EpiPen Recalls Defective Devices with Life-Threatening Malfunction

Published on Mar 28, 2017 at 1:29 pm in Product Liability.

Four batches of the life-saving anti-allergy prescription medication EpiPen have been recalled.  The recall includes more than 80,000 devices that have already been distributed worldwide.  These defective auto-injectors possess the potential for either the failure to administer a complete dose of medication or the failure to activate at all.

EpiPen, a product of Mylan Pharmaceuticals, is a medication prescribed by a doctor to treat emergency cases of allergic reaction to food, medications, and insect stings and bites.  It is an injection device that automatically dispenses a premeasured dose of drugs containing epinephrine, a chemical that narrows blood vessels and opens airways in the lungs.  Epinephrine is used to reverse the dangerous symptoms of allergic reaction, such as severe low blood pressure, wheezing, severe skin itching, and hives.

The affected batches are those containing EpiPen 300 microgram adrenaline injection auto-injectors.  Alphapharm, a generic drug manufacturing company owned by Mylan Pharmaceuticals, released an online statement saying, “The failure of the auto-injector to activate may result in patients not receiving the required dose of adrenaline, resulting in the worsening of symptoms of anaphylaxis or anaphylactic reactions, which could be life-threatening.”

According the the Therapeutic Goods Administration (TGA), there have already been two confirmed reports of these auto-injectors failing to activate correctly and no way to know how many others have been used.  Patients are advised to check the batch number and expiry date on either their Epipen label or on the end of its carton.  The affected devices can be returned to any pharmacy and replaced for free.  The four defective batches are:


Batch Number Expiry
5FA665 April 2017
5FA6651 April 2017
5FA6652 April 2017
5FA6653 April 2017


The TGA is advising patients to keep their affected auto-injectors until they are able to replace them and using them if they need to.  The TGA also cautions patients that should they be required to use their affected injector, they may need to apply more force than normal to activate it.  In their online statement, Alphapharm said, “At this time, EpiPen Jr. 150 microgram adrenaline injection syringe auto-injectors and all other batches of EpiPen 300 microgram adrenaline injection syringe auto-injectors are unaffected and are not subject to this recall.”

Drug manufacturers are required to make certain that every product they produce is safe for every consumer.  Negligent behavior and failure to properly test products for safety can place innocent patients in life-threatening situations.  Thomas Law Offices, Louisville, KY product liability lawyer, is dedicated to holding drug manufacturers responsible.  If you or someone you love has been the victim of a defective medical drug or device, our experienced legal team can help.  Contact Thomas Law Office today for a free, zero-obligation consultation of your case.