PRA number
2020/18764
Published date
Product description
Tenofovir Disoproxil Emtricitabine Mylan 300/200 tenofovir disoproxil maleate 300 mg and emtricitabine 200 mg film coated tablets
All batches within expiry
ARTG: 265834
Prescription Medicine 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.
All batches within expiry
ARTG: 265834
Prescription Medicine 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.
Reasons the product is recalled
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.
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.
The hazards to consumers
A broken or split tablet may lead to ineffective dosing, which may increase the risk of adverse health effects.
What consumers should do
Consumers that have been prescribed Tenofovir Disoproxil Emtricitabine Mylan 300/200 should consult their treating physician for advice.
Consumers that have any unexpired product should return the product to their pharmacist for a refund.
A TGA web statement can be found at https://www.tga.gov.au/alert/tenofovir-disoproxil-emtricitabine-mylan-3…
For further information, please contact Alphapharm on 1800 274 276.
Consumers that have any unexpired product should return the product to their pharmacist for a refund.
A TGA web statement can be found at https://www.tga.gov.au/alert/tenofovir-disoproxil-emtricitabine-mylan-3…
For further information, please contact Alphapharm on 1800 274 276.
Supplier
Traders who sold this product
Chemists and Pharmacies
Where the product was sold
Nationally
Recall advertisements and supporting documentation
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.