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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
5/14/2025Balaxi Healthcare Honduras, S de R.L.

Unknown

HONDURASCLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
5/14/2025Balaxi Healthcare Honduras, S de R.L.

Unknown

HONDURASDICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
5/14/2025MEDIPRODUCTS SA

Guatemala

GUATEMALACIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
5/14/2025CAPLIN POINT LABORATORIOS

Honduras

HONDURASCIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
5/14/2025CAPLIN POINT LABORATORIOS

Honduras

HONDURASAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
5/14/2025MC Compania Farmaceutica

unknown

HONDURASPREDNISONE (GLUCOCORTICOID)
75UNAPPROVED
5/14/2025CAPLIN POINT HONDURAS

Tegucigalpa

HONDURASBENZOIC ACID (PHARMACEUTIC NECESSITY - ANTIFUNGAL AGENT)
75UNAPPROVED
5/14/2025Acromax Dominicana Sa

Santo Domingo

DOMINICAN CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
5/14/2025P.T. Nipro Indonesia Jaya

Karawang

INDONESIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/14/2025Baxter, S.A. De C.V.

Jiutepec

MEXICOSODIUM CHLORIDE (REPLENISHER)
75UNAPPROVED
5/14/2025SCOTT-EDIL PHARMACIA LTD.

Unknown

INDIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
5/14/2025Mediproducts Laboratorios

Unknown

GUATEMALADIHYDROXYALUMINUM AMINOACETATE (ANTACID)
75UNAPPROVED
5/14/2025Panzyma Laboratories

Unknown

NICARAGUAANTIBIOTIC N.E.C.
75UNAPPROVED
5/14/2025Mediproducts Laboratorios

Unknown

GUATEMALAANTIBIOTIC N.E.C.
75UNAPPROVED
5/14/2025Rowa Pharmaceuticals Limited

Cork

IRELANDANTIBIOTIC N.E.C.
75UNAPPROVED
5/14/2025CSPC Ouyi Pharmaceutical Co., Ltd.

Shijiazhuang

CHINAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
5/14/2025Laboratorios Silanes, S.A. de C.V.

Toluca

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/14/2025Laboratorios Francelia

Tegucigalpa

HONDURASMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/14/2025BALAXI HEALTHCARE DOMINICANA

Santo Domingo

DOMINICAN LORATADINE (ANTI-ASTHMATIC)
75UNAPPROVED
5/14/2025Balaxi Healthcare Honduras, S de R.L.

Unknown

HONDURASMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/14/2025LABOR ATORIOS GROSSMAN SA DE CV

Coyoacan

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/14/2025OMEGA NUTRITION

Hidalgo Del Parral

MEXICOSOY PROTEIN POWDER (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)
75UNAPPROVED
5/14/2025J. C. Udeozor & Sons Global Industries

Benin City

NIGERIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/13/2025C.K Frozen Foods Yangon Company Limited

Yangon

MYANMARTHREADFIN
9SALMONELLA
5/13/2025R-pure Agro Specialities (FZE)

Sharjah

UNITED ARACAPSICUMS (CAYENNE CHILI, HOT PEPPERS), GROUND, CRACKED (SPICE)
9SALMONELLA
5/13/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
9SALMONELLA
5/13/2025UNION MEDICO APS

Copenhagen

DENMARKCATHETER INTRODUCER
39043904
39053905
5/13/2025Alimentos Maravilla S.A.

Guatemala

GUATEMALAFRUIT BEVERAGE BASE, N.E.C.
3886FSVP VIO
5/13/2025THAI ARGI FOODS PUBLIC COMPANY L

Samut Prakan

THAILANDCOCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS
3886FSVP VIO
5/13/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
+2 more
5/13/2025Swedish Match North Europe

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
+1 more
5/13/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
+1 more
5/13/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
5/13/2025DONGGUAN MEIBANGNUO TECHNOLOGY C

Dongguan

CHINAE-CIGARETTE, KIT
3842TP NO PMTA
3843TP NO SE
5/13/2025DONGGUAN QINING TECHNOLOGY CO.,LTD

Dongguan

CHINAE-CIGARETTE, KIT
3842TP NO PMTA
3843TP NO SE
5/13/2025SHENZHEN YOUME INFORMATION TECHNOLOGY CO., LTD

Shenzhen

CHINAELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
5/13/2025PREMIUM POUCH FINLAND OY

Helsinki

FINLANDNICOTINE DELIVERY PRODUCT, NEC
3781TPNOWRNLBL
3842TP NO PMTA
+2 more
5/13/2025NICOTOBACCO FACTORY

Montera

POLANDNICOTINE DELIVERY PRODUCT, NEC
3781TPNOWRNLBL
3842TP NO PMTA
+2 more
5/13/2025INSURGENT VENTURES III

Gentofte

DENMARKNICOTINE DELIVERY PRODUCT, NEC
3781TPNOWRNLBL
3842TP NO PMTA
+2 more
5/13/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3781TPNOWRNLBL
3842TP NO PMTA
+3 more
5/13/2025MICROZERO AB

Goteborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3781TPNOWRNLBL
3842TP NO PMTA
+3 more
5/13/2025VAHDAM TEAS PVT LT

Noida

INDIAASHWAGANDHA (HERBAL & BOTANICAL TEAS)
3560SUPPL GMP
5/13/2025VAHDAM TEAS PVT LT

Noida

INDIAASHWAGANDHA (HERBAL & BOTANICAL TEAS)
3560SUPPL GMP
5/13/2025A.H. GEIGER

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
3500RXLABEL
5/13/2025A.H. GEIGER

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
3500RXLABEL
5/13/2025A.H. GEIGER

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
3500RXLABEL
5/13/2025A.H. GEIGER

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
3500RXLABEL
5/13/2025A.H. GEIGER

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
3500RXLABEL
5/13/2025A.H. GEIGER

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
3500RXLABEL
5/13/2025A.H. GEIGER

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
3500RXLABEL

About This Page

This page displays 50 FDA import refusal records from 18 countries. Records on this page involve violations including 75 (UNAPPROVED), 9 (SALMONELLA), 3904 (3904), 3905 (3905), 3886 (FSVP VIO) and 8 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 522 of 10,077 • Showing records 26,051-26,100 of 503,850 total