EPIPEN 300 microgram (µg) Adrenaline Injection Syringe Auto-Injector (AUST R 42978)

Official notice

22 Mar 2017

Last checked

22 Mar 2017

High riskACCC

An official ACCC notice concerns EPIPEN 300 microgram (µg) Adrenaline Injection Syringe Auto-Injector (AUST R 42978). 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. Published 2017-03-22.

What to do now

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: 5FA665, 5FA6651, 5FA6652 or 5FA6653 and an expiry of Apr 17, 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.

Recall number

fbe7f754-59d4-4a77-91f6-1b69c190eb94

Official notice

2017-03-22

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

es, with, 5FA665, 5FA6651, 5FA6652, 5FA6653

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Affected products

Product 1

The following batches of EpiPen® 300 microgram (µg) Adrenaline Injection Syringe Auto-Injectors (AUST R 42978) used for the treatment of allergic emergencies (anaphylaxis)): Batch number 5FA665 Expiry Apr 17 Batch number 5FA6651 Expiry Apr 17 Batch number 5FA6652 Expiry Apr 17 Batch number 5FA6653 Expiry Apr 17

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

high

Recall details

Recall number

fbe7f754-59d4-4a77-91f6-1b69c190eb94

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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