Apotex Inc.
🚨 Critical Risk
FEI: 3002906944 • North York, Ontario • CANADA
FEI Number
3002906944
Location
North York, Ontario
Country
CANADAAddress
150 Signet Dr, , North York, Ontario, Canada
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2025 | 62CCY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/20/2025 | 61NDA66FLUOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/20/2025 | 61NDA66FLUOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 61MDY42LEVETIRACETAM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2024 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2024 | 62OCA18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/16/2023 | 62ODB44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/16/2023 | 62ODB27DOXAZOSIN MESYLATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/8/2023 | 62ICA32METHOTREXATE SODIUM (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/2/2023 | 60LIC99ANALGESIC, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 5/26/2023 | 62GDA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2023 | 61LDY44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2023 | 61NCF76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2023 | 62JDA13DONEPEZIL HCL (ANTI-PARKINSONIAN) | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 61JDA16ROSUVASTATIN CALCIUM | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 63ADA02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | Division of Southeast Imports (DSEI) | |
| 8/30/2022 | 61NDY03AMITRIPTYLINE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/25/2022 | 62TDY06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2021 | 64BCA24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2021 | 61MCB99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2021 | 64BCA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/27/2020 | 63EDA28PROPAFENONE HYDROCHLORIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/4/2020 | 61WCB45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2020 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/2/2020 | 64LDA56PREDNISONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/2/2020 | 64BCA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/6/2020 | 62OCA05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/8/2019 | 66NDB06ARIPIPRAZOLE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/8/2019 | 61JDB16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/8/2019 | 62ODB05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/5/2019 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/25/2019 | 61TIA31DOMPERIDONE | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 9/25/2019 | 66MIA91OXAZEPAM (TRANQUILIZER) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 8/2/2019 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2019 | 64FCA15BROMOCRIPTINE (ENZYME INHIBITOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2019 | 62CCE68OLMESARTAN MEDOXOMIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/12/2019 | 55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/12/2019 | 62OCA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/18/2019 | 64SDA29ZOPICLONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/13/2019 | 62OCA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/26/2018 | 62KCY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2018 | 60CDB49PHENYLPROPANOLAMINE HCL (ADRENERGIC) | Division of Southeast Imports (DSEI) | |
| 7/9/2018 | 61NDY60TRAZODONE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2018 | 61NDB84DESVENLAFAXINE SUCCINATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2018 | 61JDY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/9/2018 | 63BCQ02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/5/2017 | 63JCA99CHELATING AGENT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/30/2017 | 56EDH61MINOCYCLINE HYDROCHLORIDE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2017 | 61NCA83ESCITALOPRAM OXALATE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/24/2017 | 56EDH22DOXYCYCLINE HYCLATE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/23/2017 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/12/2017 | 62CDC30HYDRALAZINE HCL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2017 | 61WDY45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2017 | 62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/7/2017 | 62KDA10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2016 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2016 | 64BCA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2016 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/25/2016 | 61UDY05TAMOXIFEN CITRATE (ANTI-ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2016 | 66SCY51TADALAFIL | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/21/2016 | 61JDV08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/21/2016 | 60XDB15ACEBUTOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/30/2016 | 61LCC38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/16/2016 | 61JDC08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/27/2016 | 61TCY31DOMPERIDONE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/25/2016 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/20/2016 | 64UCA99INHIBITOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/20/2016 | 62CDA65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/27/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/18/2016 | 61PCA11GLYBURIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/18/2016 | 60XCA02METOPROLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/11/2016 | 56ECY21DOXYCYCLINE MONOHYDRATE (TETRACYCLINES) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/14/2016 | 61NCA03AMITRIPTYLINE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/22/2016 | 60SAA25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2016 | 61PCY09GLIPIZIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/7/2016 | 61NCA69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/28/2015 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/28/2014 | 64BCH24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/13/2014 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 12/21/2013 | 61MCA35DIVALPROEX SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/11/2012 | 62ODB44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/6/2012 | 61PCY26METFORMIN (ANTI-DIABETIC) | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
| 4/26/2012 | 66MCA78CLOBAZAM (TRANQUILIZER) | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
| 12/29/2011 | 61JDA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 12/29/2011 | 61JDA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 12/29/2011 | 61JDA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 12/29/2011 | 61JDA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 12/13/2011 | 61NCA76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2011 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2011 | 61LCA13WARFARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2011 | 61PIA55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2011 | 61PBY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/29/2011 | 64TCA01AZATHIOPRINE (IMMUNOSUPPRESSIVE) | New Orleans District Office (NOL-DO) | |
| 9/26/2011 | 61PAA26METFORMIN (ANTI-DIABETIC) | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
| 7/7/2011 | 61ECA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/27/2011 | 62LCE37QUININE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2011 | 61NCA29FLUOXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/3/2011 | 65VCA56ZOLPIDEM TARTRATE (SEDATIVE) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Apotex Inc.'s FDA import refusal history?
Apotex Inc. (FEI: 3002906944) has 151 FDA import refusal record(s) in our database, spanning from 10/9/2001 to 12/9/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Apotex Inc.'s FEI number is 3002906944.
What types of violations has Apotex Inc. received?
Apotex Inc. has been cited for 7 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Apotex Inc. come from?
All FDA import refusal data for Apotex Inc. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.