DULAC FARMACEUTICI 1982 SRL · 99-39 · ITALY
For DULAC FARMACEUTICI 1982 SRL · 99-39 · ITALY, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is ITALY; product is Diosmin Expert Omniven 500; 80 tablets | Diosmin Expert Omniven 500; 40 tablets | Diosmin Expert Omniven 500; 80 tablets | Diosmin Expert Omniven 500; 40 tablets; product code is 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 05/23/2024; address is Via San Quintino 28 , Turin, ITALY, verified against its source on 2026-09-16.
- Firm
- DULAC FARMACEUTICI 1982 SRL verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- ITALY verified
- Address
- Via San Quintino 28 , Turin, ITALY verified
- Date published
- 05/23/2024 verified
- Product code
- 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. each item verified
- Product
- Diosmin Expert Omniven 500; 80 tablets | Diosmin Expert Omniven 500; 40 tablets | Diosmin Expert Omniven 500; 80 tablets | Diosmin Expert Omniven 500; 40 tablets each item verified
- FDA notes
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act. Label contains information in multiple languages but do not repeat all required information in English and the multiple languages. (21 CFR 101.15(c)). Section 403(s)(2)(B) of the Act. Label of the dietary supplements fails to include the statement of identity as a “dietary supplement” on the principal display panel (21 CFR 101.3(a), (b), and (g)). Section 403(y) of the Act. Missing domestic address or domestic phone number through which a responsible person may receive a report of a serious adverse event with the dietary supplements (Section 761 of the Act). Section 403(q) of the Act. Serving sizes incorrect. Label declares serving size as “1 Tablet,” but the directions state 1 to 2 tablets per day, which does not correlate with the serving size. (21 CFR 101.96(b) and 21 CFR 101.12(b), Table 2); Label statement: “The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.” There is no provision in 21 CFR 101.36 for this statement. The “Servings Per Container” does not correlate with the Serving Size declared in the Supplement Facts. “Supplement Facts” must be set to the full width of the nutrition label (21 CFR 101.36(e)(1)). Section 403(i)(2) of the Act. No common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). Botanical dietary ingredient name must be declared by the standardized common name (SCN) as noted in the reference Herbs of Commerce. In the absence of an SCN, the botanical ingredient must be declared by its Latin binomial name. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act. Label contains information in multiple languages but do not repeat all required information in English and the multiple languages. (21 CFR 101.15(c)). Section 403(s)(2)(B) of the Act. Label of the dietary supplements fails to include the statement of identity as a “dietary supplement” on the principal display panel (21 CFR 101.3(a), (b), and (g)). Section 403(y) of the Act. Missing domestic address or domestic phone number through which a responsible person may receive a report of a serious adverse event with the dietary supplements (Section 761 of the Act). Section 403(q) of the Act. Serving sizes incorrect. Label declares serving size as “1 Tablet,” but the directions state 1 to 2 tablets per day, which does not correlate with the serving size. (21 CFR 101.96(b) and 21 CFR 101.12(b), Table 2); Label statement: “The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.” There is no provision in 21 CFR 101.36 for this statement. The “Servings Per Container” does not correlate with the Serving Size declared in the Supplement Facts. “Supplement Facts” must be set to the full width of the nutrition label (21 CFR 101.36(e)(1)). Section 403(i)(2) of the Act. No common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). Botanical dietary ingredient name must be declared by the standardized common name (SCN) as noted in the reference Herbs of Commerce. In the absence of an SCN, the botanical ingredient must be declared by its Latin binomial name. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act. Label contains information in multiple languages but do not repeat all required information in English and the multiple languages. (21 CFR 101.15(c)). Section 403(s)(2)(B) of the Act. Label of the dietary supplements fails to include the statement of identity as a “dietary supplement” on the principal display panel (21 CFR 101.3(a), (b), and (g)). Section 403(y) of the Act. Missing domestic address or domestic phone number through which a responsible person may receive a report of a serious adverse event with the dietary supplements (Section 761 of the Act). Section 403(q) of the Act. Serving sizes incorrect. Label declares serving size as “1 Tablet,” but the directions state 1 to 2 tablets per day, which does not correlate with the serving size. (21 CFR 101.96(b) and 21 CFR 101.12(b), Table 2); Label statement: “The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.” There is no provision in 21 CFR 101.36 for this statement. The “Servings Per Container” does not correlate with the Serving Size declared in the Supplement Facts. “Supplement Facts” must be set to the full width of the nutrition label (21 CFR 101.36(e)(1)). Section 403(i)(2) of the Act. No common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). Botanical dietary ingredient name must be declared by the standardized common name (SCN) as noted in the reference Herbs of Commerce. In the absence of an SCN, the botanical ingredient must be declared by its Latin binomial name. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act. Label contains information in multiple languages but do not repeat all required information in English and the multiple languages. (21 CFR 101.15(c)). Section 403(s)(2)(B) of the Act. Label of the dietary supplements fails to include the statement of identity as a “dietary supplement” on the principal display panel (21 CFR 101.3(a), (b), and (g)). Section 403(y) of the Act. Missing domestic address or domestic phone number through which a responsible person may receive a report of a serious adverse event with the dietary supplements (Section 761 of the Act). Section 403(q) of the Act. Serving sizes incorrect. Label declares serving size as “1 Tablet,” but the directions state 1 to 2 tablets per day, which does not correlate with the serving size. (21 CFR 101.96(b) and 21 CFR 101.12(b), Table 2); Label statement: “The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.” There is no provision in 21 CFR 101.36 for this statement. The “Servings Per Container” does not correlate with the Serving Size declared in the Supplement Facts. “Supplement Facts” must be set to the full width of the nutrition label (21 CFR 101.36(e)(1)). Section 403(i)(2) of the Act. No common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). Botanical dietary ingredient name must be declared by the standardized common name (SCN) as noted in the reference Herbs of Commerce. In the absence of an SCN, the botanical ingredient must be declared by its Latin binomial name. each item verified
What the source says
DULAC FARMACEUTICI 1982 SRL Date Published : 05/23/2024 Via San Quintino 28 , Turin, ITALY 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 05/23/2024 Desc: Diosmin Expert Omniven 500; 80 tablets Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act. Label contains information in multiple languages but do not repeat all required information in English and the multiple languages. (21 CFR 101.15(c)). Section 403(s)(2)(B) of the Act. Label of the dietary supplements fails to include the statement of identity as a “dietary supplement” on the principal display panel (21 CFR 101.3(a), (b), and (g)). Section 403(y) of the Act. Missing domestic address or domestic phone number through which a responsible person may receive a report of a serious adverse event with the dietary supplements (Section 761 of the Act). Section 403(q) of the Act. Serving sizes incorrect. Label declares serving size as “1 Tablet,” but the directions state 1 to 2 tablets per day, which does not correlate with the serving size. (21 CFR 101.96(b) and 21 CFR 101.12(b), Table 2); Label statement: “The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.” There is no provision in 21 CFR 101.36 for this statement. The “Servings Per Container” does not correlate with the Serving Size declared in the Supplement Facts. “Supplement Facts” must be set to the full width of the nutrition label (21 CFR 101.36(e)(1)). Section 403(i)(2) of the Act. No common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). Botanical dietary ingredient name must be declared by the standardized common name (SCN) as noted in the reference Herbs of Commerce. In the absence of an SCN, the botanical ingredient must be declared by its Latin binomial name. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 05/23/2024 Desc: Diosmin Expert Omniven 500; 40 tablets Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act. Label contains information in multiple languages but do not repeat all required information in English and the multiple languages. (21 CFR 101.15(c)). Section 403(s)(2)(B) of the Act. Label of the dietary supplements fails to include the statement of identity as a “dietary supplement” on the principal display panel (21 CFR 101.3(a), (b), and (g)). Section 403(y) of the Act. Missing domestic address or domestic phone number through which a responsible person may receive a report of a serious adverse event with the dietary supplements (Section 761 of the Act). Section 403(q) of the Act. Serving sizes incorrect. Label declares serving size as “1 Tablet,” but the directions state 1 to 2 tablets per day, which does not correlate with the serving size. (21 CFR 101.96(b) and 21 CFR 101.12(b), Table 2); Label statement: “The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.” There is no provision in 21 CFR 101.36 for this statement. The “Servings Per Container” does not correlate with the Serving Size declared in the Supplement Facts. “Supplement Facts” must be set to the full width of the nutrition label (21 CFR 101.36(e)(1)). Section 403(i)(2) of the Act. No common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). Botanical dietary ingredient name must be declared by the standardized common name (SCN) as noted in the reference Herbs of Commerce. In the absence of an SCN, the botanical ingredient must be declared by its Latin binomial name. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/23/2024 Desc: Diosmin Expert Omniven 500; 80 tablets Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act. Label contains information in multiple languages but do not repeat all required information in English and the multiple languages. (21 CFR 101.15(c)). Section 403(s)(2)(B) of the Act. Label of the dietary supplements fails to include the statement of identity as a “dietary supplement” on the principal display panel (21 CFR 101.3(a), (b), and (g)). Section 403(y) of the Act. Missing domestic address or domestic phone number through which a responsible person may receive a report of a serious adverse event with the dietary supplements (Section 761 of the Act). Section 403(q) of the Act. Serving sizes incorrect. Label declares serving size as “1 Tablet,” but the directions state 1 to 2 tablets per day, which does not correlate with the serving size. (21 CFR 101.96(b) and 21 CFR 101.12(b), Table 2); Label statement: “The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.” There is no provision in 21 CFR 101.36 for this statement. The “Servings Per Container” does not correlate with the Serving Size declared in the Supplement Facts. “Supplement Facts” must be set to the full width of the nutrition label (21 CFR 101.36(e)(1)). Section 403(i)(2) of the Act. No common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). Botanical dietary ingredient name must be declared by the standardized common name (SCN) as noted in the reference Herbs of Commerce. In the absence of an SCN, the botanical ingredient must be declared by its Latin binomial name. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/23/2024 Desc: Diosmin Expert Omniven 500; 40 tablets Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act. Label contains information in multiple languages but do not repeat all required information in English and the multiple languages. (21 CFR 101.15(c)). Section 403(s)(2)(B) of the Act. Label of the dietary supplements fails to include the statement of identity as a “dietary supplement” on the principal display panel (21 CFR 101.3(a), (b), and (g)). Section 403(y) of the Act. Missing domestic address or domestic phone number through which a responsible person may receive a report of a serious adverse event with the dietary supplements (Section 761 of the Act). Section 403(q) of the Act. Serving sizes incorrect. Label declares serving size as “1 Tablet,” but the directions state 1 to 2 tablets per day, which does not correlate with the serving size. (21 CFR 101.96(b) and 21 CFR 101.12(b), Table 2); Label statement: “The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.” There is no provision in 21 CFR 101.36 for this statement. The “Servings Per Container” does not correlate with the Serving Size declared in the Supplement Facts. “Supplement Facts” must be set to the full width of the nutrition label (21 CFR 101.36(e)(1)). Section 403(i)(2) of the Act. No common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4). Botanical dietary ingredient name must be declared by the standardized common name (SCN) as noted in the reference Herbs of Commerce. In the absence of an SCN, the botanical ingredient must be declared by its Latin binomial name.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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