Dulac Farmaceutici 1982 SRL

7 records, newest first. Each line links to the FDA page it came from.

Refusal charges, in plain English

• UNAPPROVED6 refused lines

  Unapproved new drug

  The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

• DIETARYLBL5 refused lines

  Not identified as a dietary supplement

  The label appeared not to identify the product with the term "dietary supplement" (which may be modified with the name of an ingredient).

• NCONTACT5 refused lines

  No U.S. adverse event contact on supplement label

  The dietary supplement label appeared not to show a U.S. address or phone number through which a serious adverse event can be reported.

• NO ENGLISH5 refused lines

  Required label information not in English

  Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.

• NUTRIT LBL5 refused lines

  Nutrition information missing from label

  The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

• HEALTH C3 refused lines

  Unauthorized nutrient content or health claim

  The label or labeling appeared to carry a nutrient content claim or health claim that is not authorized.

• LIST INGRE3 refused lines

  Ingredients not listed

  The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).

• STD NAME2 refused lines

  STD NAME

Questions about Dulac Farmaceutici 1982 SRL

Is Dulac Farmaceutici 1982 SRL on an FDA import alert?

Yes. As of October 26, 2026, Dulac Farmaceutici 1982 SRL is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for diosmin expert omniven 500; 40 tablets; diosmin expert omniven 500; 80 tablets; FDA published the listing on May 23, 2024.

Has FDA refused shipments from Dulac Farmaceutici 1982 SRL?

Yes. FDA refused 6 shipment lines from Dulac Farmaceutici 1982 SRL between May 28, 2024 and January 17, 2025. The most recent, on January 17, 2025, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Dulac Farmaceutici 1982 SRL's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 6 lines) and DIETARYLBL (not identified as a dietary supplement, 5 lines).

What is Dulac Farmaceutici 1982 SRL's FEI number?

Dulac Farmaceutici 1982 SRL's FDA Establishment Identifier (FEI) is 3015085870.

Can shipments from Dulac Farmaceutici 1982 SRL still enter the U.S.?

Shipments of diosmin expert omniven 500; 40 tablets; diosmin expert omniven 500; 80 tablets from Dulac Farmaceutici 1982 SRL can be detained without physical examination under Import Alert 99-39; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).