HQ Team
May 2, 2023: TruVision Health, a US-based healthcare company, will recall its dozen unapproved dietary products after an FDA inspection found them to be adulterated.
The dietary supplement products contain unapproved dietary ingredients hordenine and octodrine, according to a statement from the FDA.
The products were packaged as capsules in blister packs and cardboard cartons or as stick packs in 30 count bags.
It was sold at Truvy.com to retail customers and received through US postal service or a parcel carrier like UPS. The products were distributed throughout the US, Canada, Australia, New Zealand, Germany, Ireland and England.
The product bears the TruVision Health or the Truvy brand name. Lot numbers are located on the end flap of the carton or the back of the bag.
High blood pressure
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.
Currently, hordenine is not an approved dietary ingredient in dietary supplements.
Octodrine appears to be similar to another stimulant called dimethylamylamine, 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.
Potentially dangerous
Since no data exists on its metabolic pathway in humans, the use of octodrine during exercise is potentially dangerous, according to the statement.
Dimethylamylamine is considered to be a substance that does not meet the statutory definition of a dietary ingredient and is an unsafe food additive.
Consumers who have purchased these products should stop using them immediately.
The FDA urged customers to return the products to TruVision Health for a full refund — return shipping is paid by the consumer — an exchange, or discard the product.
