Import Refusal Records
503,850 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 12/5/2025 | LUPIN LTD Sikkim | INDIA | ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED |
| 12/5/2025 | Morepen Laboratories Limited Solan | INDIA | DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED |
| 12/5/2025 | ALKEM LABORATORIES SIKKIM | INDIA | MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 75UNAPPROVED |
| 12/5/2025 | Sun Pharma Laboratories Ltd Dist Kamrup | INDIA | CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED |
| 12/5/2025 | USV PVT LTD Manjubar | INDIA | METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED |
| 12/5/2025 | SUNGLOW LIFESCIENCE Kattankulam | INDIA | GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED |
| 12/5/2025 | Samarth Life Sciences Pvt Ltd Solan | INDIA | LEUCOVORIN CALCIUM (ANTI-ANEMIC) | 75UNAPPROVED |
| 12/5/2025 | Bajaj Healthcare Ltd Vadodara | INDIA | SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) | 75UNAPPROVED |
| 12/5/2025 | SIDMAK LABORATORIES Abrama | INDIA | NITROGLYCERIN (TAB) (VASODILATOR) | 75UNAPPROVED |
| 12/5/2025 | EMS PHARMA Hortolandia | BRAZIL | CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED |
| 12/5/2025 | THERMAEX FARMACEUTICAL Sao Paulo | BRAZIL | ESTRADIOL (ESTROGEN) | 75UNAPPROVED |
| 12/5/2025 | BIOLAB SANUS Sao Paulo | BRAZIL | ESTROGEN N.E.C. | 75UNAPPROVED |
| 12/5/2025 | Farmoquimica S.A. Rio De Janeiro | BRAZIL | PROGESTERONE (PROGESTIN) | 75UNAPPROVED |
| 12/5/2025 | EMS PHARMA Hortolandia | BRAZIL | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 12/5/2025 | ELABORADO POR LA FABRIFARMA SA Bogota | COLOMBIA | VALPROIC ACID (ANTI-CONVULSANT) | 75UNAPPROVED |
| 12/5/2025 | Swati Spentose Private Limited Vapi | INDIA | PENTOSAN POLYSULFATE SODIUM (URICOSURIC) | 75UNAPPROVED |
| 12/5/2025 | CALOX LABORATORIES SA Tenango | GUATEMALA | KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 12/5/2025 | RAMOS LABORATORIES SA Managua | NICARAGUA | AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED |
| 12/5/2025 | RAMOS LABORATORIES SA Managua | NICARAGUA | DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED |
| 12/5/2025 | ASPEN LABORATORIES Tecla | GUATEMALA | MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED |
| 12/5/2025 | NICATE LABORATORIES Managua | NICARAGUA | ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED |
| 12/5/2025 | LARRY LABORATORIES SA Santa Fe | EL SALVADO | MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED |
| 12/5/2025 | Colgate Palmolive Centro America Sa Guatemala | GUATEMALA | ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED |
| 12/5/2025 | NATURAL MEDICALS LABORATORIES SA Managua | NICARAGUA | ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED |
| 12/5/2025 | MARLEN LEMUR LABORATORIES SA San Jose | COSTA RICA | NICOTINAMIDE (NIACINAMIDE) (VITAMIN) | 75UNAPPROVED |
| 12/5/2025 | PHARMA INTERNAYTIONAL LABORATORI Salvador | EL SALVADO | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 12/5/2025 | MERCK-MEXICO SA Mexico Df | MEXICO | VITAMIN B1 (THIAMINE) | 75UNAPPROVED |
| 12/5/2025 | BIOMEDIKAL LABORATORIES S Salvador | EL SALVADO | VITAMIN B1 (THIAMINE) | 75UNAPPROVED |
| 12/5/2025 | PRO LABS Guatemala City | GUATEMALA | CALCIUM (MINERAL) | 75UNAPPROVED |
| 12/5/2025 | ANPHAR LABORATORIES SA MEDICAL C Tegucigalpa | HONDURAS | AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 12/5/2025 | CAPLIN POINT LABORATORIES OF GUA Guatemala City | GUATEMALA | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 12/5/2025 | LANCASCO LABORATORIES SA Mixco | GUATEMALA | DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 12/5/2025 | CAPLIN POINT LABORATORIES OF GUA Guatemala City | GUATEMALA | DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 12/5/2025 | Alkem Laboratories Ltd Mumbai | INDIA | VIT D | 75UNAPPROVED |
| 12/5/2025 | VANGUARD THERAPUETICS PVT LTD Hyderabad | INDIA | LOPERAMIDE (ANTI-PERISTALTIC) | 75UNAPPROVED |
| 12/5/2025 | Micro Labs Ltd Bangalore | INDIA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 12/5/2025 | ADINEX HEALTHCARE New Delhi | INDIA | DOMPERIDONE | 75UNAPPROVED |
| 12/5/2025 | ABBOTT INDIA Mumbai | INDIA | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 12/5/2025 | Blue Cross Lab Ltd Mumbai | INDIA | DICYCLOMINE HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED |
| 12/5/2025 | THE HIMALAYA DRUG COMPANY Tehsil Paonta Sahib | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/5/2025 | THE HIMALAYA DRUG COMPANY Tehsil Paonta Sahib | INDIA | AMLA (HERBAL & BOTANICALS, NOT TEAS II) | 75UNAPPROVED |
| 12/5/2025 | THE HIMALAYA DRUG COMPANY Tehsil Paonta Sahib | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/5/2025 | OPTHO LIFE SCIENCES PVT LTD Noida | INDIA | CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 75UNAPPROVED |
| 12/5/2025 | AJANTA PHARMA LTD MUMBAI | INDIA | GATIFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED |
| 12/5/2025 | ENTOD PHARM Mumbai | INDIA | EMOLLIENT, LUBRICANT, N.E.C. | 75UNAPPROVED |
| 12/5/2025 | AVYUKT PHARMACEUTICALS Karnataka | INDIA | BETAHISTINE HCL (VASODILATOR) | 75UNAPPROVED |
| 12/5/2025 | RABNEW PHARMA Panchkula | INDIA | LEVOCETIRIZINE DIHYDROCHLORIDE | 75UNAPPROVED |
| 12/5/2025 | CIPLA LTD Mumbai | INDIA | EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED |
| 12/5/2025 | Apex Laboratories Private Ltd Alathur | INDIA | VITAMIN B2 (RIBOFLAVIN) | 75UNAPPROVED |
| 12/5/2025 | Icpa Health Products Ltd Ankleshwar | INDIA | ACONITE (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED |
About This Page
This page displays 50 FDA import refusal records from 9 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 74 of 10,077 • Showing records 3,651-3,700 of 503,850 total