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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
5/28/2025Biologische Heilmittel Heel Gmbh

Baden-Baden

GERMANYANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
5/28/2025Kolmar Korea Co., Ltd. - Gwanjeong Factory

Chungcheongnam-Do

SOUTH KOREEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
5/28/2025STEFI BIO PALACE

Cotonou

BENINMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/28/2025Woodstock Sterile Solutions Inc

Woodstock

UNITED STAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/28/2025NANOPHARMA INDUSTRIA E COSMETICO

Irati

BRAZILTESTOSTERONE (ANDROGEN)
75UNAPPROVED
5/28/2025NANOPHARMA INDUSTRIA E COSMETICO

Irati

BRAZILESTRADIOL (ESTROGEN)
75UNAPPROVED
5/28/2025NANOPHARMA INDUSTRIA E COSMETICO

Irati

BRAZILPROGESTERONE (PROGESTIN)
75UNAPPROVED
5/28/2025Suraksha Pharma Pvt Ltd

Uttarakhand

INDIAVITAMIN, N.E.C.
75UNAPPROVED
5/28/2025Sun Pharma

Sikkim

INDIADROSPIRENONE
75UNAPPROVED
5/28/2025AKUMS DRUED & PHARMACEUTICALS LT

Haridwar

INDIAPROGESTERONE (PROGESTIN)
75UNAPPROVED
5/28/2025NOVELL PHARMACEUTICAL LABORATORI

West Java

INDONESIAESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)
75UNAPPROVED
5/28/2025AstraZeneca AB

Sodertalje

SWEDENESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)
75UNAPPROVED
5/28/2025TITAN CENTER

Tangerang

INDONESIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
5/28/2025Sanbe Farma

Jabar

INDONESIACIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
5/28/2025Daiichi Sankyo Co., Ltd.

Chuo

JAPANPRASUGREL HYDROCHLORIDE (ANTI-COAGULANT)
75UNAPPROVED
5/28/2025LAPI LABORATORIES

Serang

INDONESIAMETHYLPREDNISOLONE (GLUCOCORTICOID)
75UNAPPROVED
5/28/2025Les Laboratories Servier Industrie

Gidy

FRANCEIVABRADINE (CARDIAC DEPRESSANT)
75UNAPPROVED
5/28/2025Merck Healthcare KGaA

Darmstadt

GERMANYBISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
5/28/2025Novartis Pharmaceuticals Corporation

East Hanover

UNITED STAAMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
5/28/2025SRI DWI ANGGRAINI LANGI

Lama

INDONESIASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
5/28/2025PT DIPA PHARMALAB INTERSAINS

Jakarta

INDONESIAVITAMIN D2 (CALCIFEROL)
75UNAPPROVED
5/28/2025Novo Nordisk A/S

Bagsvard

DENMARKESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)
75UNAPPROVED
5/28/2025VITABIOTICS LIMITED

London

UNITED KINCALCIUM (MINERAL)
75UNAPPROVED
5/28/2025MEGALABS

Canelones

URUGUAYMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/28/2025ALLERGAN INDIA PRIVATE LIMITED

Bengaluru

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/28/2025ALLERGAN INDIA PRIVATE LIMITED

Bengaluru

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/28/2025MYLAN SPECIAL PRODUCT LINE SPA

Anagni

ITALYCLOMIPHENE CITRATE (GONAD-STIMULATING PRINCIPLE)
75UNAPPROVED
5/28/2025LABORATORIOS COFASA

Santa Tecla

EL SALVADOMEBENDAZOLE (ANTHELMINTIC)
75UNAPPROVED
5/28/2025LABORATORIOS COFASA

Santa Tecla

EL SALVADOFLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
5/28/2025GLOBAL FARMA

Sao Paulo

BRAZILCLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS)
75UNAPPROVED
5/28/2025LABORATORIOS ANCALMO

Antiguo Cuscatlan

EL SALVADOKETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
5/28/2025LAMFER S A

Mixco

GUATEMALAA-FUNGAL N.E.C.
75UNAPPROVED
5/28/2025CORPORACION BONIMA SA DE CV

San Salvador

EL SALVADOBETAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
5/28/2025LABORATORIOS FARDEL

San Salvador

EL SALVADOLEVOFLOXACIN (ANTI-BACTERIAL, PART III)
75UNAPPROVED
5/28/2025LABORATORIOS PHARMEDIC

Soyapango

EL SALVADOMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
5/28/2025LABORATORIOS SILANES SA DE CV

Toluca

MEXICOVITAMIN B1 (THIAMINE)
75UNAPPROVED
5/28/2025INCEPTA PHARMACEUTICALS

Zirabo

BANGLADESHMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/28/2025SKM SIDDHA AND AYURVEDA COMPANY

Erode

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
5/28/2025BAIDYANATH AYURVED BHAWAN PVT LTD

Kolkata

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
5/28/2025Takeda Pharma Ltda

Jaguariuna

BRAZILSULFASALAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
5/28/2025UNITED BIOCEUTICALS PRIVATE LIMI

Haridwar

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
5/28/2025PRODUCT OS MAVER, CA DE CV

Jalisco

MEXICODEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD)
75UNAPPROVED
5/28/2025Productos Farmaceuticos, SA de CV

Rincon De Romos

MEXICOAMANTADINE HCL (ANTI-VIRAL)
75UNAPPROVED
5/28/2025RB HEALTH MEXICO SA DE CV

Granada

MEXICOBENZOCAINE (ANESTHETIC)
75UNAPPROVED
5/28/2025SANOFI AVENTIS DE MEXICO SA CV

Mexico City

MEXICODIPYRONE (ANALGESIC)
75UNAPPROVED
5/28/2025LABORATORIOS MAVER SA DE CV

Jalisco

MEXICOAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
5/28/2025Nova Nordisk

Mississauga

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
5/28/2025SANOFI INDIA LTD

Sanand

INDIAIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
5/28/2025INDILLINA PHARMACEUTICALS LTD

Bassian

INDIAOMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
75UNAPPROVED
5/28/2025Piramal Enterprise Ltd

Maharashtra

INDIAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
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About This Page

This page displays 50 FDA import refusal records from 19 countries. Records on this page involve violations including 75 (UNAPPROVED). Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 487 of 10,077 • Showing records 24,301-24,350 of 503,850 total