Medicine recalls
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| The United States: Beta Labs, LTD announces a recall of dietary supplements Oxyphen, Phentalene, Phen FX, and Red Vipers due to possible health risk |
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Beta Labs, LTD ("Beta"), dietary supplement retailer, is recalling Oxyphen XR Lot #s 200910 and 200911, Phentalene Lot # 58800512, Phen FX Lot # 1205129, and Red Vipers Lot # 1205128 (hereinafter referred to as the "Products"). The recall was initiated on 15 June 2013, after a review of recent FDA communications related to 1,3 dimethylamylamine ("DMAA"). The Products contain DMAA and are all in capsule form. DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. The FDA has warned that DMAA is potentially dangerous to health. See http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm347270.htm. Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems. A number of adverse effects associated with DMAA containing dietary supplements have been reported to the FDA. The FDA has also warned that DMAA is not a dietary ingredient and thus, is not Dietary Supplement Health and Education Act (DSHEA) compliant. Beta distributes dietary supplements to retailers. The Products were sold via telephone in all fifty (50) United States. There have been no reports of adverse events associated with these Products to date. Consumers who may have purchased the affected lot numbers of Oxyphen, Phentalene, Phen FX, and/or Red Vipers should immediately discontinue using the products and contact their health care professional if they have experienced any adverse effects.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm358236.htm
In Hong Kong, the above products are not registered pharmaceutical products. The press release regarding the control of DMAA as pharmaceutical product in Hong Kong since 1 April 2013 was issued and posted on the website of Drug Office on 7 December 2012.
Ends/ Monday, June 24, 2013
Issued at HKT 12:30
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