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.
See a list of details to help identify the product
Reason 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-300200
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-300200
For further information, please contact Alphapharm on 1800 274 276.
Details to help identify the product
Supplier running the recall
Who sold the product
Chemists and Pharmacies
Identifying numbers
Other identifying numbers
AUST R 265834
Where the product was sold
Nationally
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2020/18764 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.