YANG WOO BIO CO. LTD. · 66-41 · KOREA (THE REPUBLIC OF)
For YANG WOO BIO CO. LTD. · 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 Digest Soothe Granule Packs | Digest Soothe Granule Packs | Digest Soothe Granule Packs | Digest Soothe Granule Packs; product code is 54 F - - -- Herbal & Botanicals(other than teas) | 54 K - - -- Herbal & Botanicals(other than teas) II | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 12/30/2019; address is Dongsan-Myun , 175 Wonmudong-Gil; Dongsan-Myeon , Chuncheon, Gangwon KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- YANG WOO BIO CO. LTD. 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
- Dongsan-Myun , 175 Wonmudong-Gil; Dongsan-Myeon , Chuncheon, Gangwon KOREA (THE REPUBLIC OF) verified
- Date published
- 12/30/2019 verified
- Product code
- 54 F - - -- Herbal & Botanicals(other than teas) | 54 K - - -- Herbal & Botanicals(other than teas) II | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Digest Soothe Granule Packs | Digest Soothe Granule Packs | Digest Soothe Granule Packs | Digest Soothe Granule Packs each item verified
- FDA notes
- This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'. | This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'. | This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'. | This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'. each item verified
What the source says
YANG WOO BIO CO. LTD. Date Published : 12/30/2019 Dongsan-Myun , 175 Wonmudong-Gil; Dongsan-Myeon , Chuncheon, Gangwon KOREA (THE REPUBLIC OF) 54 F - - -- Herbal & Botanicals(other than teas) Date Published: 12/30/2019 Desc: Digest Soothe Granule Packs Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'. 54 K - - -- Herbal & Botanicals(other than teas) II Date Published: 12/30/2019 Desc: Digest Soothe Granule Packs Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'. 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. Date Published: 12/30/2019 Desc: Digest Soothe Granule Packs Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 12/30/2019 Desc: Digest Soothe Granule Packs Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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