HPS Pharmacies wish to advise that Mylan, in consultation with the Therapeutic Goods Administration (TGA), have given notice of a conditional release of EpiPen® Jr. as follows:
EpiPen® Jr. Auto-Injector
Adrenaline 150 mcg/0.3 mL
Supplies of EpiPen® Jr. are currently constrained and expected to return to normal by the end of January 2020. Due to the critical nature of this medicine, the TGA has allowed one batch to be released that has not met all of the required quality specifications. The conditional release applies to batch 9KC652.
Several batches of EpiPen® Jr. have been identified as being contaminated with low levels of pralidoxime, a medication used to treat organophosphate poisoning. The maximum amount of pralidoxime detected in EpiPen® Jr. is less than 0.1% of the therapeutic dose recommended for organophosphate poisoning in children and is not expected to cause adverse effects. While the manufacturer has taken steps to prevent contamination of future batches of EpiPen® Jr., the risk of not having adrenaline available to treat anaphylaxis is far greater than the risk of being exposed to a very small amount of pralidoxime.
Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Alphapharm on 1800 274 276.