DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o.
FDA import alert and refusal historyZagreb-slobostina, CroatiaFEI 3009204575
As of October 26, 2026, DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. (Zagreb-slobostina, Croatia) is on the red list of FDA Import Alert 99-39 (Imported foods that appear to be misbranded) for myko san agarikon.1 medicinal mushroom supplement; lentifom mushroom extract; myko san agarikon plus mushroom extract, published by FDA on May 21, 2024, and has 3 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- IA 99-39 · red list
- Last import refusal
- Herbals & botanicals (not teas), n.e.c. · UNAPPROVED
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o.
4 records, newest first. Each line links to the FDA page it came from.
2024
- Import alert listingListed on Import Alert 99-39red listMyko San Agarikon.1 Medicinal Mushroom Supplement; Lentifom Mushroom Extract; Myko San Agarikon Plus Mushroom ExtractSource
2023
- Import refusalSource
Refused, 3 lines in one entry: Herbals & botanicals (not teas), n.e.c.UNAPPROVEDEntry SCS-1208948-2Show 3 linesHide lines
- Refused, Herbals & botanicals (not teas), n.e.c.UNAPPROVEDEntry SCS-1208948-2Source
- Refused, Herbals & botanicals (not teas), n.e.c.UNAPPROVEDEntry SCS-1208948-2Source
- Refused, Herbals & botanicals (not teas), n.e.c.UNAPPROVEDEntry SCS-1208948-2Source
Refusal charges, in plain English
- UNAPPROVED3 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.
Questions about DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o.
- Is DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. on an FDA import alert?
- Yes. As of October 26, 2026, DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for myko san agarikon.1 medicinal mushroom supplement; lentifom mushroom extract; myko san agarikon plus mushroom extract; FDA published the listing on May 21, 2024.
- Has FDA refused shipments from DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o.?
- Yes. FDA refused 3 shipment lines from DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. on December 29, 2023. The most recent, on December 29, 2023, was herbals & botanicals (not teas), n.e.c., charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o.'s shipments?
- The most frequent charge is UNAPPROVED (unapproved new drug, 3 lines).
- What is DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o.'s FEI number?
- DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o.'s FDA Establishment Identifier (FEI) is 3009204575.
- Can shipments from DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. still enter the U.S.?
- Shipments of myko san agarikon.1 medicinal mushroom supplement; lentifom mushroom extract; myko san agarikon plus mushroom extract from DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. 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).
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