EPIPEN 300 (NZ)

Notice Date

Wednesday 22 March 2017

Product Description

EPIPEN 300 microgram (µg) Adrenaline Injection Syringe Auto-Injector.

The following batches of EpiPen® 300 microgram (µg) Adrenaline Injection Syringe Auto-Injectors used for the treatment of allergic emergencies (anaphylaxis)):

Batches 5FA665 and 5FA6652.

Defect

There is a potential that these devices may contain a defective part that may result in the device failing to activate or requiring increased force to activate.

Hazards

The failure of the auto-injector to activate may result in patients not receiving the required dose of adrenaline, causing the worsening of symptoms of anaphylaxis or anaphylactic reactions, which could be life threatening.

What To Do

Consumers should check if they have a 300 µg EpiPen® (yellow carton and label) and if so, check the batch number and expiry. The batch number and expiry can be found on the label of the pen or on the end of the carton.

If the EpiPen® 300µg has the following batch numbers: batches 5FA665 and 5FA6652, it needs to be replaced with a new one as soon as possible.

Consumers should return it to their pharmacist who will replace the EpiPen® 300µg from the affected batch with an EpiPen® 300µg from a different batch at no cost.

Consumers must keep their current EpiPen® until they get a replacement and use it if required.

At this time, EpiPen® Jr 150µg Adrenaline Injection Syringe Auto-Injectors and all other batches of EpiPen® 300µg Adrenaline Injection Syringe Auto-Injectors are unaffected and are not subject to this recall.

Where Sold

Nationally

Traders Selling Product

Pharmacies

Official Reference

PRA No. 2017/15984

Organisation Name

Mylan New Zealand Ltd
+64 9 579 2792