The findings have prompted the company in question – Universal ABC Beauty Supply – to issue a voluntary recall for the products on the basis that they are unapproved and therefore their “safety and effectiveness (…) is unknown”.
Sibutramine is a controlled substance that can cause high blood pressure, seizures, tachycardia (rapid heart beat), palpitations, heart attack or stroke. The company has discontinued distribution of the products in question.
The lab tests by FDA follow on from a previous agency clamp-down on adulterated weight-loss supplements. At the end of 2008 and the start of 2009, FDA identified around 70 fraudulent products as containing undeclared active pharmaceutical ingredients including sibutramine, rimonabant, phenolphthalein and bumetanide.
The agency requested voluntary recalls and warned that it would take further enforcement action of necessary.