You are here

Tenofovir Disoproxil Emtricitabine Mylan 300/200

Recall - potential for split tablets to lead to ineffective dose

23 December 2020

Consumers and health professionals are advised that Alphapharm Pty Ltd, in consultation with the TGA, is undertaking a recall of all batches of Tenofovir Disoproxil Emtricitabine Mylan 300/200 tablets due to the potential for broken/split tablets. If an affected tablet was not consumed entirely, this could result in an ineffective dose.

Tenofovir Disoproxil Emtricitabine Mylan 300/200 is prescribed:

  • 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.

Anyone with unexpired Tenofovir Disoproxil Emtricitabine Mylan 300/200 tablets should return them to their pharmacy for a refund.

picture of the tablets

Cracking is evident in these tablets.

picture of the tablet box

Information for consumers

If you or someone you provide care for have been prescribed Tenofovir Disoproxil Emtricitabine Mylan 300/200 please consult your treating physician for individual advice.

Patients should return the tablets to your pharmacist for a refund.

For further information call Alphapharm customer support on 1800 274 276.

Information for health professionals

If you are treating a patient with Tenofovir Disoproxil Emtricitabine Mylan 300/200 please be alert to this issue.

Arrange alternative therapy as required and advise patients to return unexpired stock to their pharmacist.

Pharmacists should place all stock on immediate hold. If patients return affected product, please provide a refund and dispense an alternative brand.

The active ingredients of the recalled product are tenofovir disoproxil maleate 300 mg and emtricitabine 200 mg.

All stock should be returned to your primary wholesale supplier and a refund will be provided.

Should you require any further information contact Alphapharm on 1800 274 276.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.