Class I — High risk. Reasonable probability of serious harm or death.
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857
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 an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Reason Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety…
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
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