Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0
Summary
The FDA issued a Class I for Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseid by Yamtun7. Reason: Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety .
Details
Source
Drug Recall
External ID
D-0654-2021
Action Date
2021-07-21
Status
Terminated
Category
drug
Product Description
Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0
Lot/Code Info: All lots distributed 07/01/2019 through 09/28/2020.
Quantity Affected: 36 capsules
Reason for Recall
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Distribution
Unknown; unable to determine due to firm's Ebay account being closed.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-11
Company
Delray Beach, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 22 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Yamtun7) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Yamtun7 have FDA actions?
This is the only FDA action we have on record for Yamtun7 in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0654-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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