Recall on Mylan PrEP

24/12/2020 Off By admin

Attention PrEP users. We have received a recall notice for Mylan PrEP below:

 

URGENT MEDICINE RECALL

TGA Ref Number: RC-2020-RN-01478-1

TENOFOVIR DISOPROXIL EMTRICITABINE MYLAN 300/200   Aust R 265834

 tenofovir disoproxil maleate 300mg and emtricitabine 200 mg film coated tablets

 

ALL BATCHES WITHIN EXPIRY

 

Alphapharm Pty Ltd, following consultation with the Therapeutic Goods Administration (TGA), is initiating a consumer level recall of all batches within expiry of TENOFOVIR DISOPROXIL EMTRICITABINE MYLAN 300/200 tablets.

The consumer level recall is being requested as a precautionary measure due to the potential for broken and/or split tablets.  In the event a broken/split tablet is consumed, this may result in an ineffective dose if the tablet is not taken in its entirety.

Tenofovir Disoproxil Emtricitabine Mylan 300/200 is indicated for:

  • The treatment of HIV-infected adults over the age of 18 years, in combination with other antiretroviral agents;
  • In combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.

Patients that have been prescribed Tenofovir Disoproxil Emtricitabine Mylan 300/200 should consult their treating physician for individual advice.

Patients that have any units of unexpired stock should return them to their pharmacist for a refund.

Should you require any further information please contact 1800 274 276.

Thank you in advance for your support in this matter.