D-0879-2018 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 6, 2018
- Initiation Date
- May 17, 2018
- Termination Date
- June 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
Product Description
POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857
Reason for Recall
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.
Distribution Pattern
Nationwide.
Code Information
Lot #: 201117BL, Exp. 01/2020