Dulac Farmaceutici

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

Refusal charges, in plain English

• DIETARYLBL1 refused line

  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).

• LIST INGRE1 refused line

  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).

• NCONTACT1 refused line

  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 ENGLISH1 refused line

  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 LBL1 refused line

  Nutrition information missing from label

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

• UNAPPROVED1 refused line

  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.

Questions about Dulac Farmaceutici

Is Dulac Farmaceutici on an FDA import alert?

Yes. As of October 26, 2026, Dulac Farmaceutici 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?

Yes. FDA refused 1 shipment line from Dulac Farmaceutici on September 10, 2024. The most recent, on September 10, 2024, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as LIST INGRE (ingredients not listed).

Why did FDA refuse Dulac Farmaceutici's shipments?

The most frequent charges are DIETARYLBL (not identified as a dietary supplement, 1 line) and LIST INGRE (ingredients not listed, 1 line).

What is Dulac Farmaceutici's FEI number?

Dulac Farmaceutici's FDA Establishment Identifier (FEI) is 3019708372.

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

Shipments of diosmin expert omniven 500; 40 tablets; diosmin expert omniven 500; 80 tablets from Dulac Farmaceutici 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).