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Information updates

Food and Drug Administration (FDA) letter regarding EpiPen® adrenaline (epinephrine) autoinjectors

September 9, 2017

ASCIA has been alerted to a letter released by the FDA in the USA, regarding an investigation into the Mylan recall of EpiPen® devices earlier this year. To date, ASCIA has not received any correspondence regarding EpiPen®s failing to be discharged in an emergency situation in Australia or New Zealand. We are also not aware of any problem batches of EpiPen®s at present. We are awaiting further information from Mylan to guide further action.  In the meantime, if you have any questions you should contact Mylan Customer Service by emailing This email address is being protected from spambots. You need JavaScript enabled to view it.  or phoning 1800 274 276.

The FDA letter is available at www.marketwatch.com/story/fda-warns-of-serious-manufacturing-violations-in-letter-to-epipen-manufacturing-facility-2017-09-07-141034838

ASCIA resources, including action plans and EpiPen® instructions are available at www.allergy.org.au/anaphylaxis

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