Capsule Factory Nutraceuticals Ltd. · 66-41 · CANADA
For Capsule Factory Nutraceuticals Ltd., import alert is 66-41; country is CANADA; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is TUDCA LIVER PROTECTANT | TUDCA LIVER PROTECTANT; product code is 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 09/30/2021; address is 969 Juliana Dr , Woodstock, Ontario CANADA, verified against its source on 2026-10-01.
- Firm
- Capsule Factory Nutraceuticals Ltd. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- CANADA verified
- Address
- 969 Juliana Dr , Woodstock, Ontario CANADA verified
- Date published
- 09/30/2021 verified
- Product code
- 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- TUDCA LIVER PROTECTANT | TUDCA LIVER PROTECTANT each item verified
- FDA notes
- The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘It shows great potency in treating bile acid backup in the liver…’; ‘TUDCA can also protect and help rehabilitate the liver, and in general protects cells from free radical damage…’; ‘Research has validated TUDCA as a potent and effective treatment for repairing and supporting the liver from alcohol-induced damage, as well as from damage as a result of compounds that must do a double pass through the liver…’. | The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘It shows great potency in treating bile acid backup in the liver…’; ‘TUDCA can also protect and help rehabilitate the liver, and in general protects cells from free radical damage…’; ‘Research has validated TUDCA as a potent and effective treatment for repairing and supporting the liver from alcohol-induced damage, as well as from damage as a result of compounds that must do a double pass through the liver…’. each item verified
What the source says
Capsule Factory Nutraceuticals Ltd. Date Published : 09/30/2021 969 Juliana Dr , Woodstock, Ontario CANADA
— 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 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 09/30/2021 Desc: TUDCA LIVER PROTECTANT Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘It shows great potency in treating bile acid backup in the liver…’; ‘TUDCA can also protect and help rehabilitate the liver, and in general protects cells from free radical damage…’; ‘Research has validated TUDCA as a potent and effective treatment for repairing and supporting the liver from alcohol-induced damage, as well as from damage as a result of compounds that must do a double pass through the liver…’. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/30/2021 Desc: TUDCA LIVER PROTECTANT Notes: The product appears to be an unapproved new drug as the product’s labeling includes claims such as (not an all-inclusive list): ‘It shows great potency in treating bile acid backup in the liver…’; ‘TUDCA can also protect and help rehabilitate the liver, and in general protects cells from free radical damage…’; ‘Research has validated TUDCA as a potent and effective treatment for repairing and supporting the liver from alcohol-induced damage, as well as from damage as a result of compounds that must do a double pass through the liver…’.
— 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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