Reference Source

CHANGJAE BENKO BIO · 66-41 · KOREA (THE REPUBLIC OF)

For CHANGJAE BENKO BIO · 66-41 · KOREA (THE REPUBLIC OF), import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is KOREA (THE REPUBLIC OF); product is Victory19 Virus Out (COVID 19 Virus Remedy) | Victory19 Virus Out (COVID 19 Virus Remedy) | Victory19 Virus Out (COVID 19 Virus Remedy); product code is 29 - - - -- Drinks, Soft Drinks, and Waters | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 - - - -- Human and Animal Drugs; date published is 11/15/2021; address is Suseong , 149 Yonghak-Ro , Suseong, Daegu KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

Firm
CHANGJAE BENKO BIO verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
KOREA (THE REPUBLIC OF) verified
Address
Suseong , 149 Yonghak-Ro , Suseong, Daegu KOREA (THE REPUBLIC OF) verified
Date published
11/15/2021 verified
Product code
29 - - - -- Drinks, Soft Drinks, and Waters | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 - - - -- Human and Animal Drugs each item verified
Product
Victory19 Virus Out (COVID 19 Virus Remedy) | Victory19 Virus Out (COVID 19 Virus Remedy) | Victory19 Virus Out (COVID 19 Virus Remedy) each item verified
FDA notes
Product label of “Victory 19 Virus Out” causes this product to be a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is an article intended to diagnose, cure, mitigate, treat, or prevent disease. An example claim found on the product drug listing that documents the intended use of “Victory 19 Virus Out” includes, but may not be limited to, the following: “Prevention and treatment of COVID-19 infection”. “Victory 19 Virus Out” appears to be an unapproved new drug marketed under section 505(a) of the FD&C Act, 21 U.S.C 355(a). | Product label of “Victory 19 Virus Out” causes this product to be a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is an article intended to diagnose, cure, mitigate, treat, or prevent disease. An example claim found on the product drug listing that documents the intended use of “Victory 19 Virus Out” includes, but may not be limited to, the following: “Prevention and treatment of COVID-19 infection”. “Victory 19 Virus Out” appears to be an unapproved new drug marketed under section 505(a) of the FD&C Act, 21 U.S.C 355(a). | Product label of “Victory 19 Virus Out” causes this product to be a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is an article intended to diagnose, cure, mitigate, treat, or prevent disease. An example claim found on the product drug listing that documents the intended use of “Victory 19 Virus Out” includes, but may not be limited to, the following: “Prevention and treatment of COVID-19 infection”. “Victory 19 Virus Out” appears to be an unapproved new drug marketed under section 505(a) of the FD&C Act, 21 U.S.C 355(a). each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

CHANGJAE BENKO BIO Date Published : 11/15/2021 Suseong , 149 Yonghak-Ro , Suseong, Daegu KOREA (THE REPUBLIC OF) 29 - - - -- Drinks, Soft Drinks, and Waters Date Published: 11/15/2021 Desc: Victory19 Virus Out (COVID 19 Virus Remedy) Notes: Product label of “Victory 19 Virus Out” causes this product to be a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is an article intended to diagnose, cure, mitigate, treat, or prevent disease. An example claim found on the product drug listing that documents the intended use of “Victory 19 Virus Out” includes, but may not be limited to, the following: “Prevention and treatment of COVID-19 infection”. “Victory 19 Virus Out” appears to be an unapproved new drug marketed under section 505(a) of the FD&C Act, 21 U.S.C 355(a). 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 11/15/2021 Desc: Victory19 Virus Out (COVID 19 Virus Remedy) Notes: Product label of “Victory 19 Virus Out” causes this product to be a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is an article intended to diagnose, cure, mitigate, treat, or prevent disease. An example claim found on the product drug listing that documents the intended use of “Victory 19 Virus Out” includes, but may not be limited to, the following: “Prevention and treatment of COVID-19 infection”. “Victory 19 Virus Out” appears to be an unapproved new drug marketed under section 505(a) of the FD&C Act, 21 U.S.C 355(a). 66 - - - -- Human and Animal Drugs Date Published: 11/15/2021 Desc: Victory19 Virus Out (COVID 19 Virus Remedy) Notes: Product label of “Victory 19 Virus Out” causes this product to be a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is an article intended to diagnose, cure, mitigate, treat, or prevent disease. An example claim found on the product drug listing that documents the intended use of “Victory 19 Virus Out” includes, but may not be limited to, the following: “Prevention and treatment of COVID-19 infection”. “Victory 19 Virus Out” appears to be an unapproved new drug marketed under section 505(a) of the FD&C Act, 21 U.S.C 355(a).

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.