Epipen Jr (adrenaline (epinephrine) 0.15 mg/0.3 mL auto-injector), Alphapharm Pty Ltd (Mylan Australia), CON-346
Product name
Epipen Jr (adrenaline (epinephrine) 0.15 mg/0.3 mL auto-injector)
Sponsor name
Alphapharm Pty Ltd (Mylan Australia)
Batches
9KC652
Consent start
Consent no.
CON-346
Standard
The requirements of the United States Pharmacopeia - National Formulary (the USP) monograph Epinephrine Injection
Non-compliance with standard
The United States Pharmacopeia '“ National Formulary (the USP), in that the
requirement for use of an appropriate manufacturing process has not been met.
Conditions imposed
No more than 2,000 units of Batch 9KC652(the Contaminated Batch) can be
exported from Australia.
Alphapharm Pty Ltd (Mylan Australia) must provide the relevant regulatory
agency in any country receiving the Contaminated Batch, or any part of the
Contaminated Batch, with a copy of this decision letter before exporting the
Contaminated Batch from Australia.
Evidence of dispatch of this decision to, and receipt of the decision by,
the relevant regulatory agency of the importing country as required under
Condition 2 must be provided to the TGA by Alphapharm Pty Ltd (Mylan Australia)
within 5 working days from the date on which the Contaminated Batch, or the
relevant part of the Contaminated Batch, is exported from Australia.
Therapeutic product type
Prescription medicines