Medicine recalls
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| The United States: Update: USPlabs LLC Announces a Recall of OxyELITE Pro Dietary Supplements Due to Possible Health Risk - Recall expanded to include: Raspberry Lemonade OxyELITE Pro Super Thermo Powder |
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FDA announced that USPlabs LLC, Dallas, TX is voluntarily conducting a national recall of all lots and sizes of the OxyElite Pro dietary supplement products, which include OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules and OxyElite Pro Super Thermo Powder. These products contain Aegeline, a synthesized version of a natural extract from the Bael tree.
Epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure, concentrated in Hawaii. Investigations are ongoing into a potential causal relationship. The Company agrees with FDA that a national recall is appropriate as a precautionary measure. No other products produced by USPlabs are subject to recall.
Consumers who have purchased the products should immediately discontinue use of the product and return it to where they purchased it for a refund. Consumers should contact their healthcare professional if they have experienced any adverse effects.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm375740.htm
In Hong Kong, the above products are not registered pharmaceutical products. Related news has been released by FDA, HSA, MHRA and Health Canada, and was posted on the Drug Office website on 9 October, 15 October, 19 October, 9 November, 11 November and 16 November 2013. A press release was issued to appeal the public not to buy or use oral product labeled as OxyELITE Pro on 9 October 2013.
Ends/ Thursday, November 21, 2013
Issued at HKT 15:00
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