Recall Issued For Four Batches of Anti-Allergy EpiPen

A recall has been issued for four batches of anti-allergy EpiPen due to potential failure to activate.

In a statement posted online by Mylan-owned Alphapharm, around 80,000 EpiPen 300 microgram adrenaline injection auto-injectors that may contain a defective part, have been distributed worldwide.

“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,” the company said.

The adrenaline auto-injectors are used to treat severe allergic reactions to food, medications and insect stings and bites, among others.

The affected batches may fail to activate or it may require increased force, with potentially fatal consequences.

These include the batches number: 5FA665, 5FA6651, 5FA6652, and 5FA6653, which all have an expiry date of April 2017.

The Therapeutic Goods Administration (TGA) said there had been two confirmed reports of the auto-injectors that failed to activate properly. “The proportion of these auto-injectors that have been used is not known,” the TGA said in an online statement.

The TGA urged customers to check the batch number and expiry date on either the EpiPen’s label or on the end of its carton. It added that the affected products could be returned to pharmacies and replaced for free.

However, the TGA advised to keep affected auto-injectors until they are replaced, and using them if required, and that consumers must be “mindful” that there is a “need to apply more force than normal to activate it”.

Meanwhile, 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.”

Source: Abc.net.au