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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
7/3/2025Astellas Pharma Europe B.V.

Leiden

NETHERLANDFLUTAMIDE (ANTI-ANDROGEN)
75UNAPPROVED
7/3/2025GL Biochem (Shanghai) Ltd

Shanghai

CHINAPEPTIDE N.E.C.
75UNAPPROVED
7/3/2025TORRENT PHARMA LIMITED

Sikkim

INDIALOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
7/3/2025Ipg Life Science Ltd

Ankleshwar

INDIASPIRONOLACTONE (DIURETIC)
75UNAPPROVED
7/3/2025TORRENT PHARMA LIMITED

Sikkim

INDIANEBIVOLOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
7/3/2025ACME CHEMICALS

Davni

INDIABELOXAMIDE (ANTI-CHOLESTEREMIC)
75UNAPPROVED
7/3/2025Gillette Diversified Operations Private Limited

Ahmedabad

INDIACAMPHOR (ANTI-PRURITIC)
75UNAPPROVED
7/3/2025MACLEODS PHARMACEUTICALS LTS

Daman

GERMANYPREDNISOLONE (GLUCOCORTICOID)
75UNAPPROVED
7/3/2025Pfizer Manufacturing Deutschland GmbH

Freiburg Im Breisgau

GERMANYAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
7/3/2025MICRO LABS LIMITED

Mamring

INDIAAMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
7/3/2025DR REDDYS LABORATORIES LTD

Solan

INDIAOMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
75UNAPPROVED
7/3/2025TORRENT PHARMA LIMITED

Sikkim

INDIANEBIVOLOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
7/3/2025ZYDUS HEALTHCARE LTD

East Sikkim

INDIAATENOLOL (ANTI-ADRENERGIC)
75UNAPPROVED
7/3/2025GLAXO SMITH

Sao Paulo

BRAZILBUPROPION HCL (ANTI-DEPRESSANT)
75UNAPPROVED
7/3/2025Acme Lifetech LLP

Baddi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025SETH BROTHERS PHARMACEUTICAL

Gujarat

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025ACME LIFE TECH LLP

Solan

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025MIcro Labs Limited

Bangalore

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025Micro labs limited

Dist Solan

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025ZYDUS HEALTHCARE LIMITED PLOT

Ahmedabad

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025Cipla

Haridwar

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025MEYER ORGANICS

Bengaluru

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025GLAXOSMITHKLINE PHARMACEUTICALS

Baddi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025GLAXOSMITHKLINE PHARMACEUTICALS

Baddi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025CRESTLIFESCIENCES PVT LTD

Solon

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025Wallace Pharmaceuticals

Pradesh

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/3/2025Intas Pharmaceuticals Limited

Ahmedabad

INDIAESCITALOPRAM OXALATE
75UNAPPROVED
7/3/2025Tecnoquimicas S.A.

Cali

COLOMBIAFLAVOXATE HCL (RELAXANT)
75UNAPPROVED
7/3/2025BAYER

Bogota

COLOMBIAVITAMIN C (ASCORBIC ACID)
75UNAPPROVED
7/3/2025MK

Bogota

COLOMBIACIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
7/3/2025Pfizer Sa Colombia

Bogota

COLOMBIAPREGABALIN (ANTI-CONVULSANT)
75UNAPPROVED
7/3/2025ZAMBON COLOMBIA SA

Bogota

COLOMBIAFOSFOMYCIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
7/3/2025PET PHARMA DE MEXICO SA DE CV

Ciudad Nezahualcoyotl

MEXICOFENBENDAZOLE (ANTHELMINTIC)
75UNAPPROVED
7/3/2025KIRON

Culhuacan

MEXICOPREDNISOLONE (GLUCOCORTICOID)
75UNAPPROVED
7/3/2025NORVET

Torreon

MEXICOGABAPENTIN (ANTI-DEPRESSANT)
75UNAPPROVED
7/3/2025AGROSUR DISTRIBUTIONS

Mancana

MEXICOOMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
75UNAPPROVED
7/3/2025INNOPHARMA

Ciudad De Mexico

MEXICOSUCRALFATE (ANTACID)
75UNAPPROVED
7/3/2025INNOPHARMA

Ciudad De Mexico

MEXICOBISMUTH (ANTACID)
75UNAPPROVED
7/3/2025LABORATORIOS PISA

Mexico City

MEXICOMETRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
7/3/2025SAGE HERBALS PVT LTD

Hapur

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
7/3/2025BEHL LABORATORIES

Hapur

INDIAMETHYLPREDNISOLONE (GLUCOCORTICOID)
75UNAPPROVED
7/3/2025MEDICIAN

Bengaluru

INDIAANTI-HISTAMINIC N.E.C.
75UNAPPROVED
7/3/2025ORMED SUPREME OPTION

Lagos

NIGERIALEVOCARNITINE (NUTRIENT/TONIC)
75UNAPPROVED
7/3/2025FOWANATURALS LTD

Lagos

NIGERIAAMINOGLYCOSIDES, N.E.C.
75UNAPPROVED
7/3/2025ANCIENT ORGANIC HERBAL ENTERPRIS

Osogbo

NIGERIAVITAMIN A
75UNAPPROVED
7/3/2025GREEN VISION INTERNATIONAL LTD

Lagos

NIGERIACAMPHOR (ANTI-PRURITIC)
75UNAPPROVED
7/3/2025ALBERCHIN NATURAL CURE LIMITED

Lagos

NIGERIAASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
7/3/2025ANCIENT ORGANIC HERBAL ENTERPRIS

Osogbo

NIGERIAVITAMIN E (TOCOPHEROL)
75UNAPPROVED
7/3/2025DIVA SECRET INTERNATIONAL SDN BH

Lumpur

NIGERIACALCIUM (MINERAL)
75UNAPPROVED
7/3/2025GREEN VISION INTERNATIONAL LTD

Lagos

NIGERIASODIUM CITRATE (ALKALIZER)
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 8 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 423 of 10,077 • Showing records 21,101-21,150 of 503,850 total