EpiPen Auto-Injector Recall [Australia]

Australia/Canberra: Alphapharm Pty Ltd recalls certain batch/lots of EpiPen Auto-Injectors due to suspected component failure and consequential drug injection failure during Anaphylaxis, a serious health hazard. ACCC: http://ht.ly/tqVV30agTAX

Direct link: https://www.productsafety.gov.au/recall/alphapharm-pty-ltd-epipen-300-microgram-g-adrenaline-injection-syringe-auto-injector-aust-r-42978

Additional information:
The Australian Competition & Consumer Commission (“ACCC”) reports the following Auto-Injector Syringes are subject to this recall:

• EpiPen 300 microgram (µg) Adrenaline Injection Syringe Auto-Injectors (DIN: AUST R 42978) used for the treatment of allergic emergencies such as Anaphylaxis. The following batch/lots are affected by this recall and should be replaced immediately:
  • Batch/lot number 5FA665; expiry date: Apr 2017
  • Batch/lot number 5FA6651; expiry date: Apr 2017
  • Batch/lot number 5FA6652; expiry date: Apr 2017
  • Batch/lot number 5FA6653; expiry date: Apr 2017

==> No barcodes, UPCs, APNs or other identification numbers were listed with this recall notification.

Please consult the photograph above for details of the food’s packaging, design and retail presentation.

According to the ACCC, there is a potential that the recalled EpiPen devices may contain a defective part that may result in the device failing to activate or requiring increased force to activate, making it difficult or impossible to deliver medicine during an emergency. The failure of the Auto-Injector Pen to activate may result in patients not receiving the required dose of Adrenaline, causing the worsening of symptoms of Anaphylaxis or Anaphylactic reactions, both of which could be life threatening.

If you believe you have purchased or have in your possession any of the recalled Auto-Injectors, please do not use them. Instead, if the EpiPen Auto-Injector has the following batch numbers: 5FA665, 5FA6651, 5FA6652 or 5FA6653 and an expiry of April 2017 as listed above, it needs to be replaced with a new one as soon as possible.

Please return the device to your pharmacist who will replace the EpiPen 300µg from the affected batch with an EpiPen 300µg from a different batch/lot at no cost.

==> You should keep your current EpiPen until you get a replacement and use it if required.

Please note: this, and any other drug, should be disposed of safely and with regard to the safety of your local water supply and adherence of applicable municipal regulations. All expired and/or recalled drugs (prescription, over the counter or otherwise) should be taken to your pharmacist for proper disposal.

==> To see other recalls and notifications relating to Anaphylaxis, please search for “Anaphylaxis” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Drugs, please search for “drug” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Infants and Children, please search for “children” using the Search Box at the top of this page.

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More information about this recall:
ACCC PRA number: 2017/15984
Recalls Direct RIN: 8461-2017
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe product you purchased in Australia [external: new window opens]:
==> https://www.productsafety.gov.au/contact-us/for-consumers/report-an-unsafe-product
Search for a recalled product on the ACCC Web site [external: new window opens]:
==> http://www.productsafety.gov.au/recalls/browse-all-recalls

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E. & O. E.

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