Epipen Jr (adrenaline (epinephrine) 0.15 mg/0.3 mL auto-injector, Alphapharm Pty Ltd (Mylan Australia), CON-345

These conditions amendthe consent to import and supply batch 9KC652 of Epipen Jr(the Contaminated Batch), as granted on 29 November 2019,by revoking the conditions imposed on that consent and imposing, in their place, the following conditions1. The consent applies to the both packing runs of batch 9KC652 of Epipen Jrand therefore to both batch 9KC652 and to batch 9KC6521.2. No more than 10,000 units of the Contaminated Batch can be released for supply in the month of December, 2019.3. No more than 20,000 units of the Contaminated Batch can be supplied in Australia.4. Alphapharm Pty Ltd (Mylan Australia) must keep records relating to the source and supply of the Contaminated Batch and advise the TGA Medicine Shortages team (medicine.shortages@health.gov.au) in writing, no less than every 14 calendar days, on the stock levels held by you and also at the wholesale level, commencing 14 calendar days after the release for supply of the Contaminated Batch.5. A 'Dear Healthcare Professional' letter, with content to be approved by me, must be provided to every pharmacy prior to or at the time of supply of the Contaminated Batch. The letter must includeIdentification of pralidoxime being present as a contaminantReference to the TGA web statement on the matterAdvice that pharmacists can order stock through their usual processes. Information about how to report an adverse event to the TGA.6. Before the Contaminated Batch is released for supply, the 'Dear Healthcare Professional' letter in paragraph 5 must be provided, to The Australasian Society of Clinical Immunology and AllergyAllergy and Anaphylaxis AustraliaThe Royal Australian College of General PractitionersThe Pharmacy GuildThe Society of Hospital Pharmacists of AustraliaThe Pharmaceutical Society of Australia.7. When unaffected stock is available for supply, Alphapharm Pty Ltd (Mylan Australia) must notify the TGA Recalls Section at recalls@health.gov.au and the TGA Medicine Shortages team at medicine.shortages@health.gov.au at least 10 working days prior to release for supply. Supply cannot commence until the TGA approves a plan for appropriate retrieval of remaining units of the Contaminated Batch.