Viva Pharmaceutical Inc · 66-41 · CANADA
For Viva Pharmaceutical Inc, 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 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 2026-10-01.
- 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
What the source says
Viva Pharmaceutical Inc Date Published : 05/10/2017 13880 Viking Pl , Richmond, British Columbia 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: 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…'.
— 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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