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Albuterex Xtreme Formula

Safety advisory

21 December 2012

Albuterex Extreme Formula poses a serious risk to your health and should not be taken.

The Therapeutic Goods Administration (TGA) has tested Albuterex Xtreme Formula and found that:

• it contains the undeclared prescription substance yohimbine - despite the product label not listing this substance as an ingredient.
• consumers are advised that yohimbine is a prescription-only medicine and a prohibited import. There are currently no products on the Australian Register of Therapeutic Goods (ARTG) containing the substance yohimbine.
• it also contains the undeclared substance theophylline which is the active ingredient in several prescription only medicines included on the ARTG for bronchospasm relief and prophylaxis.
• it also contains the undeclared substance caffeine at a very high level.
• the combined stimulant effect of caffeine, yohimbine and theophylline may pose serious health risk to people consuming this product.

The supply of Albuterex Xtreme Formula is illegal.

Albuterex Xtreme Formula has 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 have bought the product online.

Information for consumers

• Stop taking Albuterex Xtreme Formula and take any product 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 Australian Customs and Border Protection Services (Customs) to help stop future shipments of Albuterex Xtreme Formula from entering Australia.

If Albuterex Extreme Formula is found at the border by Customs it 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
Email:	info@tga.gov.au

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