Class I — High risk. Reasonable probability of serious harm or death.
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
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 Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Reason Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
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