Drug Enforcement D-1150-2023

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

Status

Ongoing

Classification

Class I

Report Date

September 6, 2023

Termination Date

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Product Information

Product description
Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885
Product quantity
120 bottles
Reason for recall
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
APG SEVEN, INC
Address
12030 Sw 129th Ct Ste 205, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-1150-2023
Event ID
92892
Recall initiation date
August 3, 2023
Center classification date
September 15, 2023
Code info
All lots, Expires: 01/31/2025
More code info
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