Arzol (Silver Nitrate Applicator), (Silver Nitrate 75%, Potassium Nitrate 25%), 100-count box, Rx only, Manufacturer: Arzol…
Reason cGMP deviations: Temperature abuse
Class I — High risk. Reasonable probability of serious harm or death.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason cGMP deviations: Temperature abuse
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Reason Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
Reason Defective container: Ineffective seal between the cap and jar of the affected product.
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
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