被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: TruVision Health recalls dietary supplement products because of possible health risk (English only) |
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The US Food and Drug Administration (FDA) announces that TruVision Health LLC is recalling the following dietary supplement products because they contain the unapproved dietary ingredients hordenine and/or octodrine/DMHA (1,5-dimethylhexylamine). The affected products are:
- truCONTROL 60 Count (lot number: 13580)
- TruControl 7 Day Trifold (lot number: WKW72353)
- reFORM (lot number: 34159)
- truControl with Dynamine 60 ct (lot number: WK65081)
- TruWeight and Energy Gen 2+ 60 Count (lot number: WK71567)
- TruWeight and Energy Gen 2+ Trifold (lot number: 25173)
- Truvy 30-Day Experience Kit (lot number: 39643/42825)
- Truvy 7-Day Experience Kit (lot number: 41404)
- Truvy Boost 30-Day Experience Kit (lot number: 13993)
- TruBoost 7 Day Experience Kit (lot number: 13985)
- TruBoost Drink - Citrine Spark (lot number: PM17921F1)
- TruBoost Drink - Ruby Rev (lot number: PM18821F1)
Hordenine is possibly unsafe when taken by mouth and might cause stimulating side effects such as rapid heart rate, high blood pressure, jitteriness, nervousness, nausea, vomiting or insomnia. These adverse events are more likely to occur in sensitive sub-populations of people such as pregnant women and consumers with cardiovascular disease.
Octodrine/DMHA (1,5-dimethylhexylamine) appears to be similar to another stimulant called dimethylamylamine (DMAA), which was removed from the market in certain countries due to safety concerns. In animal studies, octodrine has been found to increase heart rate, myocardial contractility, and pain threshold. Since no data exists on its metabolic pathway in humans, the use of octodrine during exercise is potentially dangerous.
Some consumers of these products have reported experiencing chest pain, chills, diarrhea, dizziness/lightheadedness, fatigue, headache, high blood pressure, high heart rate, jitters, nausea, nervousness, rash, stomach pain or upset, sweating and vomiting.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/truvision-health-recalls-dietary-supplement-products-because-possible-health-risk
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Apr 28, 2023
Issued at HKT 13:00
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