Reference Source

Viva Pharmaceutical Inc · 66-41 · CANADA

For Viva Pharmaceutical Inc · 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 Puralor Ci Tablets | Puralor Ci Tablets; 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 05/10/2017; address is 13880 Viking Pl , Richmond, British Columbia CANADA, verified against its source on 2026-09-16.

Firm
Viva Pharmaceutical Inc 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
13880 Viking Pl , Richmond, British Columbia CANADA verified
Date published
05/10/2017 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
Puralor Ci Tablets | Puralor Ci Tablets each item verified
FDA notes
The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Puralor Ci' is…formulated to improve the nutritional status of patients with anemias of nutritional origin – specifically folate malabsorption as determined by a licensed medical practitioner, and is associated with metabolic imbalances in transformylation biochemistry. Particular emphasis is on hyperhomocysteinemia – with or without a primary disease state…; Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, childhood or other related folate-malabsorption, complications of an inborn or environmental origin…'. | The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Puralor Ci' is…formulated to improve the nutritional status of patients with anemias of nutritional origin – specifically folate malabsorption as determined by a licensed medical practitioner, and is associated with metabolic imbalances in transformylation biochemistry. Particular emphasis is on hyperhomocysteinemia – with or without a primary disease state…; Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, childhood or other related folate-malabsorption, complications of an inborn or environmental origin…'. 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

Viva Pharmaceutical Inc Date Published : 05/10/2017 13880 Viking Pl , Richmond, British Columbia CANADA 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/10/2017 Desc: Puralor Ci Tablets Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Puralor Ci' is…formulated to improve the nutritional status of patients with anemias of nutritional origin – specifically folate malabsorption as determined by a licensed medical practitioner, and is associated with metabolic imbalances in transformylation biochemistry. Particular emphasis is on hyperhomocysteinemia – with or without a primary disease state…; Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, childhood or other related folate-malabsorption, complications of an inborn or environmental origin…'. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/10/2017 Desc: Puralor Ci Tablets Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as: 'Puralor Ci' is…formulated to improve the nutritional status of patients with anemias of nutritional origin – specifically folate malabsorption as determined by a licensed medical practitioner, and is associated with metabolic imbalances in transformylation biochemistry. Particular emphasis is on hyperhomocysteinemia – with or without a primary disease state…; Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, childhood or other related folate-malabsorption, complications of an inborn or environmental origin…'.

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

Source

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