FDA Drug recall D-0879-2018
POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, U…
- FDA Drug
- Class I
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class I recall of POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, U… by Shoreside Enterprises, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0879-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-05-17 |
| Published | 2018-06-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Shoreside Enterprises |
| Distribution | US |
Product
POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857
Reason
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.
Identifiers
| upc | 638632428857 |
|---|---|
| code_info | Lot #: 201117BL, Exp. 01/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0879-2018%22
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