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The TGA advises that Albuterex Xtreme, Albutarex Xtreme and Albutarex Femme Formula, which are promoted as fat-loss products, pose a serious health risk.
Following on from a safety advisory regarding Albuterex Xtreme Formula that the TGA issued on 21 December 2012, these three products have now been recalled.
Testing by the TGA has found that batches of Albuterex Xtreme, Albutarex Xtreme and Albutarex Femme Formula contain theophylline, which is a prescription-only ingredient, and very high levels of caffeine. The analysis of Albuterex Xtreme Formula, as noted in the Albuterex Xtreme Formula 21 December 2012 safety advisory, also found that it contained yohimbine-another prescription-only ingredient.
The above ingredients are not listed on any of the respective products' labels, and combined could have a dangerous stimulant effect. Symptoms of this could range from nausea, sweating, increased heart rate, agitation and tremor, to life-threatening heart rhythms and seizures. Risks can be increased and symptoms can be worsened if other caffeine-containing products, or certain other medicines, herbal products or foods, are also consumed.
Albuterex Xtreme, Albutarex Xtreme and Albutarex Femme Formula have not been listed on the Australian Register of Therapeutic Goods (ARTG) and have not been assessed by the TGA for quality, safety or efficacy, as required under Australian law. Also, the place of manufacture is not approved by the TGA. It is illegal to supply these products or import them into Australia.
TGA investigations have found that Nutri-Sups Worldwide Distribution Pty Ltd has distributed Albuterex Xtreme, Albutarex Xtreme and Albutarex Femme Formula in Australia, and the products have been sold by local retailers.
TGA investigations have also found that some people in Australia have purchased these products online.
The TGA is working with Australian Customs and Border Protection Services to stop future shipments of Albuterex Xtreme, Albutarex Xtreme and Albutarex Femme Formula from entering Australia. If any of these products are found by Customs, they will be seized and destroyed.
Information for consumers
If you have any Albuterex Xtreme, Albutarex Xtreme or Albutarex Femme Formula:
- stop taking it
- take it to your pharmacy for safe disposal.
Do not attempt to purchase these products, either from a local retailer or online.
The TGA advises consumers to exercise extreme caution when purchasing medicines from unknown overseas internet sites. Products purchased online:
- 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.
If you have any questions or concerns arising from your use of Albuterex Xtreme, Albutarex Xtreme or Albutarex Femme Formula, contact your health professional.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines, vaccines or medical devices. Your report will contribute to our 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, vaccine or medical device.