YANG WOO BIO CO. LTD. · 66-41 · KOREA (THE REPUBLIC OF)
For YANG WOO BIO CO. LTD., import alert is 66-41; country is KOREA (THE REPUBLIC OF); import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; 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 2026-10-01.
- 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)
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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...'.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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