AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
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.
709 FDA drug recalls with this cause, newest first.
This category covers two things the label never mentions. One is chemical contamination: benzene in sunscreens and hand sanitizers, methanol in sanitizer, lead or other heavy metals in a finished product. The other is a 'supplement' that secretly contains a prescription drug - sildenafil, tadalafil, sibutramine, phenolphthalein - so that it appears to work, at the cost of dangerous interactions the buyer cannot anticipate. A large share of these recalls are Class I, because the hidden ingredient is the whole risk.
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
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