Alphapharm Pty Ltd — Tenofovir Disoproxil Emtricitabine Mylan 300/200 Tablets

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.
Photograph of Tenofovir Disoproxil Emtricitabine Mylan  Bottle
Photograph of Tenofovir Disoproxil Emtricitabine Mylan Broken/Split Tablets
Identifying features

Other identifying numbers

AUST R 265834

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.

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.

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.

Product category

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