The Therapeutic Goods Administration has issued a recall alert for one of the generic PrEP medications available in Australia and manufactured by Mylan over apprehension that split tablets would lead to ineffective dosage. All batches of Tenofovir Disoproxil Emtricitabine Mylan 300/200 pills are being recalled as precaution. 

The generic drug supplied by Mylan is available through the country’s Pharmaceutical Benefits Scheme. The recall alert is only for the medication manufactured by Mylan Australia. The other generic PrEP medication supplied by APOTEX and Lupin General Health continues to be available through PBS. 

The medication is prescribed for the treatment of HIV in adults over the age of 18 in combination with other antiretroviral agents and as pre-exposure prophylaxis (PrEP). The combination of Emtricitabine/Tenofovir has proven to be up to 99 percent effective in reducing risk of HIV transmission. 

Return Split Tablets For a Refund

TGA said that “anyone with unexpired Tenofovir Disoproxil Emtricitabine Mylan 300/200 tablets should return them to their pharmacy for a refund.” 

 According to the TGA, a recall is initiated “when there are deficiencies or potential deficiencies in safety, quality, efficacy, performance or presentation” of a drug that is already available in the market. 

In this case, generic drug manufacturing company Alpapharm owned by Mylan, after consultation with TGA said it was undertaking the recall “due to the potential for broken/split tablets”. 

If an affected tablet was not consumed entirely, this could result in an ineffective dose,” TGA said in its alert note for the public. 

In its advice for consumers, TGA said that persons who have been prescribed the tablets should consult their physician and return tablets to the pharmacist for a refund. 

Other Generic PrEP Available

Health professionals have been asked to arrange alternative therapy for their patients, while pharmacists have been told to place all stocks of the tablets on hold and to provide a refund to patients returning the product. 

Mylan PrEP is one of the generic PrEP medication that is available at a subsidy through the PBS system. Besides Mylan, the generic PrEP medication is also supplied by APOTEX and Lupin General Health. 

In April, Truvada manufactured by the American pharmaceutical company, Gilead was taken off from the PBS in favour of cheaper, but equally effective generic equivalents. 

For more information on the recalled medication, call Alphapharm customer support on 1800 274 276.


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