EPIPEN JR adrenaline (epinephrine) 0.15mg/0.3mL injection syringe auto-injector, Alphapharm Pty Ltd (Mylan Australia), CON-341

          No more than 10,000 units of the Contaminated Batch can be released for supply in the month of December, 2019.       No more than 20,000 units of the Contaminated Batch can be supplied in Australia.       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 Alphapharm Pty Ltd (Mylan Australia) and also at the wholesale level, commencing 14 calendar days after the release for supply of the Contaminated Batch.       A 'Dear Healthcare Professional' letter, with content to be approved by the TGA, must be provided to every pharmacy prior to or at the time of supply of the Contaminated Batch. The letter must include               Identification of pralidoxime being present as a contaminant       Reference to the TGA web statement on the matter       Advice that pharmacists can order stock through their usual processes       Confirmation that Epipen (adrenaline (epinephrine) 0.3mg/0.3 mL auto-injector) AUSTR42978 is unaffected by the contamination       Information about how to report an adverse event to the TGA.         5. Before the Contaminated Batch is released for supply, the 'Dear Healthcare Professional' letter in paragraph5must be provided, to           The Australasian Society of Clinical Immunology and Allergy       Allergy and Anaphylaxis Australia       The Royal Australian College of General Practitioners       The Pharmacy Guild       The Society of Hospital Pharmacists of Australia       The Pharmaceutical Society of Australia.         6. 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.