Urgent TGA Medicine Recall – EpiPen 300 batches 5FA665, 5FA6651, 5FA6652, 5FA6653 (expiry April 2017)
Apr 2, 2017
Further to the news issued on March 20, no additional batches of EpiPen® 300 adrenaline autoinjectors supplied in Australia or New Zealand have been recalled, as the most recent batches recalled were supplied in other countries.
Mar 20, 2017:
Alphapharm Pty Ltd, following consultation with the Therapeutic Goods Administration (TGA) is recalling 4 batches of EpiPen® 300 microgram adrenaline (epinephrine) autoinjectors, used for the treatment of allergic emergencies (anaphylaxis). This recall is due to the potential that these devices may contain a defective part that may result in the device failing to activate or requiring increased force to activate.
If the EpiPen fails to activate it may result in life threatening adverse events as the underlying anaphylaxis will not be treated.
The batch numbers affected (which all expire in April 2017 are as follows:
5FA665, 5FA6651, 5FA6652, 5FA6653.
If you have an EpiPen:
- Check if you have a 300 μg EpiPen® (yellow carton and label) and if you do, 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 your EpiPen® 300μg has the following batch numbers 5FA665, 5FA6651, 5FA6652 or 5FA6653 and an expiry of Apr 17, you need to replace it with a new one as soon as possible by returning to your pharmacist.
- Your pharmacist will replace the EpiPen® 300μg from the affected batch with an EpiPen® 300μg from a different batch FREE OF CHARGE.
- You must keep your current EpiPen® until you get a replacement and use it if required.
If your EpiPen® 300μg is not from a batch listed above or is a green EpiPen® Jr 150μg adrenaline autoinjector, your product is not affected by this recall and no action is required.
Alphapharm Pty Ltd sincerely regrets any inconvenience to its customers.
Further information is available on the TGA website: