Reference Source

Capsule Factory Nutraceuticals Ltd. · 66-41 · CANADA

For Capsule Factory Nutraceuticals Ltd. · 66-41 · CANADA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is CANADA; 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Capsule Factory Nutraceuticals Ltd. Date Published : 09/30/2021 969 Juliana Dr , Woodstock, Ontario CANADA 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…’.

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

Source

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