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Recall - products contain undeclared substances
Further to the information in the safety advisory below, consumers and health professionals are advised that Cleanicall, in consultation with the TGA, is recalling Maxagra capsules.
Maxagra capsules were being marketed as a herbal medicine used to treat erectile dysfunction.
This recall is being taken after TGA testing found that these capsules contained the undeclared substance sildenafil and the antibiotic oxytetracycline. Both of these substances are prescription-only medicines and could pose a serious safety risk if taken. Supplying Maxagra capsules is illegal.
Information for consumers
If you have any Maxagra capsules, do not take them. They contain ingredients that could pose a serious risk to your health.
If you have any unused Maxagra capsules, you can call Cleanicall on 03 9018 7768 to arrange return of the product.
Information for health professionals
Please be aware of the above issue and advise patients accordingly if they seek advice.
Advise your patients of the potential risks of buying therapeutic goods online.
If you have any questions or concerns about this issue, contact Cleanicall on 03 9018 7768.
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.
3 February 2016
Maxagra capsules pose a serious risk to your health and should not be taken.
The Therapeutic Goods Administration (TGA) has tested a product labelled Maxagra capsules and found that:
- the capsules contain the undeclared substance sildenafil; and
- the capsules contain the undeclared antibiotic substance oxytetracycline
Consumers are advised that sildenafil and oxytetracycline are both prescription-only substances in Australia.
The supply of Maxagra capsules containing sildenafil and oxytetracycline is illegal.
Maxagra capsules have not been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and the place of manufacture is not approved by the TGA.
TGA investigations have shown that a number of people in Australia may have bought the product online.
Information for consumers
- Stop taking Maxagra capsules and take any remaining capsules to your local pharmacy for safe disposal.
- If you have any concerns arising from your use of this product, consult your health care practitioner.
Action the TGA is taking
The TGA is working with the Australian Border Force (ABF) to help stop future shipments of Maxagra capsules from entering Australia.
If these capsules are found at the border by the ABF they will be seized and destroyed.
The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas Internet sites. Products purchased over the Internet:
- may contain undisclosed and potentially harmful ingredients
- may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.
Report counterfeit medicines and medical devices
If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:
|Phone:||1800 020 653|
|Online:||Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products|