D-0879-2018 Class I Terminated
FDA drug recall D-0879-2018 was initiated by Shoreside Enterprises Inc. on May 17, 2018 and is designated Class I. 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 … The recall status is terminated (terminated June 10, 2020). Affected quantity: Unknown.
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