Class I — High risk. Reasonable probability of serious harm or death.
Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
Mojo Nights for Her, 1 capsule, UPC 7 18122 12133 5, Distributed By: Mojo Health Lauderhill, FL 33351
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile dysfunction making this an unapproved new drug.
Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
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