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Potential to be contaminated with Listeria Monocytogenes
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.
State of CA inspection found four products that do not declare allergy statements which reflect the use of milk, wheat and eggs.
Wheat and soy is not declared.
Product may contain undeclared almonds.
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.
Results from the company lab samples revealed that some of the samples contained Listeria monocytogenes.
The firm initiated the recall based on positive results for Listeria monocytogenes obtained from a composite sample tested by a private laboratory.