HPS Pharmacies wish to advise that Bayer Australia Ltd, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a drug recall of:
Mirena® levonorgestrel 52mg intrauterine drug delivery system
The only affected batch is TU01BT1 with an expiry date of June 2019.
This recall has been initiated due to the potential for inversely mounted insertion tubes on some units of this batch. This may lead to incorrect insertion depth and an incorrect position of Mirena®, leading to decreased effectiveness or adverse events. The numbers on the defective inserter may result in ‘nine’ being read as ‘six’ and vice versa, which could create confusion part way through the insertion procedure, adding to the risk of injury.
Please inspect your stocks and quarantine all products from the batch stated above for return to your supplier for a refund.
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 Bayer on 1800 008 757.
Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.