FDA WARNING_LETTER - Investra-24hs

The FDA issued a Warning Letter to Investra-24hs for offering unapproved new drugs and misbranded drugs for sale on multiple websites, violating sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act. The FDA reviewed the listed websites and determined products like "Generic Meridia (Sibutramine)" are unapproved new drugs because they lack FDA approval and are not generally recognized as safe and effective. Meridia (sibutramine) was voluntarily withdrawn from the U.S. market in 2010 due to increased risks of heart attack and stroke.

Additionally, these products are misbranded under section 502(f)(1) of the FD&C Act because they lack adequate directions for use by a layperson, as they are prescription drugs requiring professional supervision. The FDA emphasized the inherent risk to consumers from unapproved and misbranded drugs, which may be contaminated, counterfeit, or contain incorrect ingredients. Investra-24hs is required to immediately cease marketing violative drug products and notify the FDA within 10 working days of steps taken to correct these violations and prevent recurrence. Failure to comply may result in regulatory actions such as seizure or injunction.