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EpiPen investigation outcomes

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19 December 2019

Mylan, the Australian sponsor of 150 mcg EpiPen Jr and 300 mcg EpiPen Adrenaline (epinephrine) Auto-Injectors, has advised the TGA of the outcomes of testing of EpiPen products.

Meridian Medical Technologies, the manufacturer of EpiPen products, has undertaken a thorough investigation into the presence of very low levels of another medicine, pralidoxime, in EpiPen Jr products. This included testing of batches of both the 150 mcg and 300 mcg versions of the product.

The investigation has identified that a batch of 300 mcg EpiPen (batch number 9KB643), which is available in Australia, contains trace levels of pralidoxime. However, the trace levels in this batch are in the nanogram range (one billionth of a gram), and these levels are considered to be negligible.

The TGA has reviewed the outcomes of the investigation and is satisfied that these products meet the required standards for safety. The manufacturing issue has now been fully corrected and production has resumed.

EpiPen products are critical, life-saving medicines. The TGA is committed to facilitating the ongoing availability of these medicines for Australians and continues to work closely with Mylan to ensure supply.