EpiPen 300µg recall

recall regulatory

Alphapharm is recalling several batches of EpiPen 300µg, with an expiry date of April 17

Following consultation with the TGA, Alphapharm has initiated a recall of four batches of its EpiPen 300 microgram (µg) Adrenaline Injection Syringe Auto-Injectors.

This 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

The affected batches are:

Batch number   Expiry
5FA665              Apr 17
5FA6651            Apr 17
5FA6652            Apr 17
5FA6653            Apr 17

Two reports worldwide have been confirmed of the device failing to activate in a batch of about 80,000 devices.

The failure of the autoinjector 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 recalled product was manufactured by Meridian Medical Technologies in St. Louis Missouri, USA.

Alphapharm says it is undertaking this recall as a precautionary measure and has patient safety as its first priority.

It is encouraging consumers to check whether they have a 300µg EpiPen (with the yellow carton and label) and check the batch number and expiry.

Patients with an EpiPen from the affected batches need to replace them immediately, it says.

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