List of drugs for exceptional importation and sale
Drugs included on the list for exceptional importation and sale are called "designated drugs". They are eligible for exceptional importation and sale as per sections C.10.004 to C.10.011 of the Food and Drug Regulations. This list is incorporated by reference in these regulations. Health Canada maintains and updates this list as required.
Designated drugs are eligible for exceptional importation into Canada before the date listed in the "Date importation no longer allowed" column. Products cannot be exceptionally imported after this date, but products already imported may be sold until their expiry dates.
For more information on the exceptional importation and sale of drugs, please consult the following:
- Drug shortages regulations and guidance
- Guide to the exceptional importation and sale of drugs in response to drug shortages
Supercedes: 2024-11-15
Date issued: 2024-11-23
Access the archived versions of this list associated to the Food and Drug Regulations.
Before these regulations were in force, similar provisions existed under the Second Interim Order respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19. Consult the list of drugs (now archived) that were authorized for exceptional importation under the IO no. 2.
| Brand name of drug, medicinal ingredient(s) | Dosage form, strength, route(s) of administration | Country of authorization, name of foreign regulatory authority, identifying code or number | Name of importing licensee | Lot number and quantities | Date product added to this list | Date after which drug may no longer be imported | Information to support safe use made available by importer |
|---|---|---|---|---|---|---|---|
| Idarubicin hydrochloride | 1 mg/mL in 5 mL, 10 mL, and 20 mL vials, Solution for Injection | United States of America FDA NDC 0143-9217-01 (5mL), NDC 0143-9218-01 (10mL), NDC 0143-9219-01 (20mL) | Hikma Canada Limited | N/A | October 31, 2024 | January 31, 2025 | Hikma Canada Limited 5995 Avebury Road, Suite 804 Mississauga, ON L5R 3P9 |
| Biltricide, praziquantel |
Tablet, 600 mg, oral |
Benin, 4062/93 Burkina Faso, 005742005XC112000 Cameroon, 92.07.0391 RV Congo, 007-R-92 /M2.22.01/05-113-RVC Cote D'Ivoire, E-95-0070 Gabon, 3712/94/04 Guinea, 50031 Madagascar, 31.1.1.062 Niger, 72494 Senegal, 1474 Chad, 96 500 802 Togo, SP.TG. 1371 |
Bayer Inc. | N/A | August 30, 2024 | December 31, 2024 | Bayer Inc 292 Matheson Blvd. E. Mississauga, ON L4W 5R6 Email: Canada.medinfo@bayer.com Phone: 1-800-265-7382 |
| Pantoprazole Sodium for Injection, Pantoprazole Sodium USP | Lyophilized powder for injection, 40 mg/vial, intravenous infusion | United States, Food and Drug Administration, NDC 0143-9284-10 | Hikma Canada Limited | N/A | July 26, 2024 | November 1, 2024 |
Contact Hikma Canada Limited at: Phone: 1-800-656-0793 |
| Beyfortus, nirsevimab | Solution, 50 mg/0.5 mL, Intramuscular | France, National Agency for the Safety of Medicine and Health Products, EU/1/22/1689/002 | Sanofi Pasteur Limited | N/A | July 19, 2024 | September 30, 2024 |
Contact Sanofi Pasteur Limited at 1755 Steeles Avenue West, Toronto, Ontario, Canada, M2R 3T4. Telephone: 1-800-265-7927 |
| Beyfortus, nirsevimab | Solution, 100 mg/1 mL, Intramuscular | France, National Agency for the Safety of Medicine and Health Products, EU/1/22/1689/005 | Sanofi Pasteur Limited | N/A | July 19, 2024 | September 30, 2024 |
Contact Sanofi Pasteur Limited at 1755 Steeles Avenue West, Toronto, Ontario, Canada, M2R 3T4. Telephone: 1-800-265-7927 |
| Calcitriol Injection USP, Calcitriol | Sterile solution, 1 mcg/mL, intravenous | United States, Food and Drug Administration, NDC 72266-251-10 | Sterimax Inc. | N/A | June 14, 2024 | May 1, 2025 |
Contact SteriMax Inc. at: |
| Colestyramin Orifarm, cholestyramine resin | Powder for suspension, 4 g, oral | Denmark, Danish Medicines Agency, 59339 | Septa Pharmaceuticals Inc. | N/A | August 14, 2024 | October 15, 2024 |
Septa Pharmaceuticals Inc. 7035 Maxwell Road, Unit 2 |
| Orencia, abatacept | Solution, 125 mg/mL, Subcutaneous | Saudi Arabia, Saudi Food and Drug Authority, 1-960-14 | Bristol-Myers Squibb Canada Co. | N/A | June 7, 2024 | August 31, 2024 | Contact Bristol-Myers Squibb Canada Co. at: 2344, Boul. Alfred-Novel, St-Laurent, Quebec, Canada, H4S 0A4 Telephone: 1-866-463-6267 Email: medical.canada@bms.com |
| Moxifloxacin Injection, Moxifloxacin Hydrochloride | Solution, 400 mg/250 mL, Intravenous | United States of America, Food and Drug Administration, NDC# 63323-850-74 (package); 63323-850-04 (single bag) | Fresenius Kabi Canada Ltd. | N/A | May 10, 2024 | August 31, 2024 |
Fresenius Kabi Canada 165 Galaxy Boulevard, Suite 100 Main Phone: 905-770-3711 Medical Information: Canada_MedInfo@fresenius-kabi.com |
| Bupivacaine with Adrenaline (Epinephrine) Injection (0.25%), Bupivacaine hydrochloride and Adrenaline (Epinephrine) | Solution (sterile) | United Kingdom, Medicines and Healthcare products Regulatory Agency, PL 12762/0556 | SteriMax Inc. | N/A | May 28, 2024 | December 5, 2024 |
Contact SteriMax Inc. at: 2770, Portland Drive, Oakville, ON, L6H 6R4 Phone: +1-800-881-3550 E-mail: medinfo@sterimaxinc.com |
| Bupivacaine with Adrenaline (Epinephrine) Injection (0.5%), Bupivacaine hydrochloride and Adrenaline (Epinephrine) | Solution (sterile); epidural | United Kingdom, Medicines and Healthcare products Regulatory Agency, PL 12762/0557 | SteriMax Inc. | N/A | May 28, 2024 | September 1, 2024 |
Contact SteriMax Inc. at: 2770, Portland Drive, Oakville, ON, L6H 6R4 Phone: +1-800-881-3550 E-mail: medinfo@sterimaxinc.com |
| Aminophylline Injection, aminophylline hydrate | Solution for injection, 25mg/ml, intravenous injection | UK, MHRA PL 12762/0559 |
Septa Pharmaceuticals Inc. | 25,000 ampoules | April 26, 2024 | July 31, 2024 | Contact Septa Pharmaceuticals Inc. at: Phone: +1-905-564-5665 or Address: 7035 Maxwell Road, Unit 2, Mississauga, ON, Canada, L5S 1R5 Email: orders@septapharma.com |
| Aminophylline Injection, aminophylline dihydrate | Solution for injection, 25mg/ml, intravenous injection | Greece, National Organization for Medicines, 40869/09/03-03-2010 GR | Juno Pharmaceuticals Corp. |
Lot Number: 2401527 Qty: 10000 ampoules |
April 18, 2024 | July 31, 2024 | Contact Juno Pharmaceuticals Corps. at: 402-2233 Argentia Road, Mississauga, Ontario, L5N 2X7, Canada Phone: +1 905-829-3838 |
| ORENCIA, abatacept | Solution, 125 mg/ml, Subcutaneous | United States, Food and Drug Administration, National Drug Code (NDC): 0003-2188-11 | Bristol-Myers Squibb Canada Co. | N/A | May 24, 2024 | August 31, 2024 | Contact Bristol-Myers Squibb Canada Co. at: 2344, Boul. Alfred-Novel, St-Laurent, Quebec, Canada, H4S 0A4 Telephone: 1-866-463-6267 Email: medical.canada@bms.com |
| Thiamine HCl Injection USP, Thiamine hydrochloride | Liquid, 200 mg/2 mL (100 mg/mL), Intramuscular or Intravenous use | United States, Food and Drug Administration, National Drug Code (NDC) 0641-6228-25 | Hikma Canada Limited | N/A | March 21, 2024 | June 1, 2024 | Contact Hikma Canada Limited 5995 Avebury Road, Suite 804 Mississauga, ON, L5R 3P9 |
| TECHNETIUM TC 99M TSC, Sodium Thiosulfate Pentahydrate | Powder for Solution, Kit, 2mg/vial, Oral, Intravenous, Intraperitoneal | United States, Food and Drug Administration, National Drug Code (NDC): 45567-0030-1 | GE Healthcare Canada Inc. | 500 kits | February 9, 2024 | June 1, 2024 | Contact GE Healthcare Canada Inc. at: 1919 Minnesota Court Mississauga, ON, Canada, L5N 0C9 Phone: 866-281-7545 |
| Fomicyt, Fosfomycin | Powder for solution, 4g/vial, Intravenous | United Kingdom, Medicines and Healthcare products Regulatory Agency, PL15011/0017, PA1972/001/001 | Verity Pharmaceuticals Inc. | N/A | November 30, 2023 | May 30, 2024 | Contact Verity Pharmaceuticals Inc. at: 2560 Matheson Blvd. East, Suite 220, Mississauga, Ontario, Canada, L4W 4Y9 Phone: 416-800-7771 |
| Glyceryl trinitrate sublingual spray, glyceryl trinitrate | Sublingual solution, 400 µg/metered spray, sublingual | United Kingdom, Medicines and Healthcare products Regulatory Agency, PL 18190/0013 | Juno Pharmaceuticals Corp. | N/A | November 6, 2023 | April 30, 2024 | Contact Juno Pharmaceuticals Corp. at: 402-2233 Argentina Road, Mississauga, Ontario, Canada, L5N 2X7 Phone: 905-829-3838 Fax: 905-829-3810 |
| Glucose Intravenous Infusion 50% w/v, glucose | Solution, 25 g/50 mL, Intravenous | United Kingdom, Medicines and Healthcare products Regulatory Agency, PL 01502/0005R | Juno Pharmaceuticals Corp. | N/A | November 7, 2023 | January 15, 2025 | Contact Juno Pharmaceuticals Corp. at: 402-2233 Argentina Road, Mississauga, Ontario, Canada, L5N 2X7 Phone: 905-829-3838 Fax: 905-829-3810 |
| Vigabatrin Tablets, USP, Vigabatrin | Tablet, 500 mg, Oral | United States, Food and Drug Administration, National Drug Code (NDC): 43598-651-01 |
Dr. Reddy's Laboratories Canada Inc. | N/A | October 31, 2023 | March 15, 2024 | Contact: Dr. Reddy's Laboratories Canada Inc. 5580 Explorer Drive, Suite 204, Mississauga, ON, L4W 4Y1, Canada |
| Prazosin hydrochloride | Capsules, 1 mg, 2 mg, 5 mg, Oral |
United States, Food and Drug Administration, National Drug Code (NDC) 1mg: 62332-691-31; 2mg: 62332-692-31; 5 mg 62332-693-31 |
SteriMax Inc. | N/A | August 4, 2023 | December 31, 2024 | Contact SteriMax Inc. 2770 Portland Drive, Oakville, Ontario, L6H6R4 |
| Fasturtec, Rasburicase | Powder for Solution, 1.5mg/vial, Intravenous | United Kingdom, Medicines and Healthcare products Regulatory Agency, PLGB 04425/0821 | Sanofi-Aventis Canada Inc. | N/A | June 22, 2023 | September 15, 2023 | Contact Sanofi-Aventis Canada Inc. at: 1755 Steeles Avenue West, Toronto, Ontario, Canada, M2R 3T4 Email: CAINTERNET@sanofi.com Phone: 1-800-265-7927 |
| Sabril, vigabatrin | Tablet, 500mg, Oral | United States, Food and Drug Administration, National Drug Code (NDC): 67386-111-01 | Lundbeck Canada Inc. | N/A | May 31, 2023 | December 31, 2023 | Contact Lundbeck Canada Inc. at: 2600 Alfred-Nobel Suite 400, St-Laurent, Quebec, Canada, H4S 0A9 Phone: 514-844-8515 Fax: 514-844-5495 |
| 10% Premasol, amino acid solution | Solution, 500 mL, Intravenous | United States, Food and Drug Administration, National Drug Code (NDC): 0338-1130-03 |
Baxter Corporation | N/A | May 31, 2023 | August 5, 2023 | Contact Baxter Corporation at 1-888-719-9955 |
| Potassium Chloride 15% w/v Concentrate for Solution for Infusion | Solution, 15% w/v, Intravenous | United Kingdom, Medicines and Healthcare products Regulatory Agency, PL 24598/0003 | Juno Pharmaceuticals Corp. | N/A | October 13, 2023 | June 30, 2024 | Juno Pharmaceuticals Corp.
402-2233 Argentia Road, Mississauga, Ontario, L5N 2X7 Canada |
| Primene 10%, amino acid solution | Solution, 250 mL, Intravenous | Brazil, Agência Nacional de Vigilância Sanitária (ANVISA), PCA3CG133N79D | Baxter Corporation | N/A | June 12, 2023 | August 5, 2023 | Contact Baxter Corporation at 1-888-719-9955 |
| 10% Premasol, amino acid solution | Solution, 1000 mL, Intravenous | United States, Food and Drug Administration, National Drug Code (NDC): 0338-1130-04 |
Baxter Corporation | N/A | May 31, 2023 | August 5, 2023 | Contact Baxter Corporation at 1-888-719-9955 |
|
Calcitonin Salmon Injection, USP, Synthetic Calcitonin Salmon |
Solution, 200 units Intramuscular (IM), Subcutaneous (SC) |
United States, US FDA, NDC 24201-400-02 | Hikma Canada Limited | N/A | April 24, 2023 | September 30, 2024 |
Contact Hikma Canada Limited at: 5995 Avebury Road, Suite 804 |
| Cytogam, Cytomegalovirus Immunoglobulin Intravenous (Human) | 2500 mg/ml | United States of America, Food and Drug Administration, National Drug Code (NDC): 70257-532-51 | Accuristix | N/A | April 21, 2023 | January 15, 2024 | KI BioPharma LLC 3 Germay Dr, Unit 4 #1302 Wilmington, Delaware, USA 19804 Email: ki_pv@kibiopharma.com Phone: 1 866-916-0077 |
| Lipiodol Ultra Fluid solution, iodine (ethiodized oil) |
38% w/w (380 mg iodine/g or 480 mg iodine/mL) |
United Kingdom |
Methapharm Inc. | N/A | October 25, 2024 | December 31, 2024 |
Contact Methapharm |
| Gleostine, lomustine |
Capsules, 10 mg & 40 mg, oral | United States, Food and Drug Administration, National Drug Code (NDC): 58181-3040-5 (10 mg), 58181-3041-5 (40 mg) |
Septa Pharmaceuticals Inc. | N/A | October 17, 2024 | December 31, 2025 |
Septa Pharmaceuticals Inc. |
| Lithium Carbonate Capsules, USP, lithium carbonate | Capsules, 150 & 300 mg, oral | United States, Food and Drug Administration, National Drug Code (NDC): 0054-2526-25 (150 mg), 0054-2527-25 (300 mg), 0054-2527-31 (300 mg) | Hikma Canada Limited | N/A | September 24, 2024 | February 28, 2025 | Hikma Canada Limited 5995 Avebury Road, Suite 804 Mississauga, Ontario CanadaL5R 3P9 Phone: 1-800-656-0793 |
| Pantoprazole Sodium for Injection, pantoprazole sodium sesquihydrate | Powder for injection, 40 mg/vial, intravenous infusion | United States, United States, Food and Drug Administration, National Drug Code (NDC) 65219-433-01 (vial), NDC: 65219-433-15 (carton) | Fresenius Kabi Canada Ltd | N/A | September 26, 2024 | April 4, 2025 | Fresenius Kabi Canada165 Galaxy Boulevard, Suite 100 Toronto, ON M9W 0C8Main Phone: 905-770-3711 Toll Free: 1-877-779-7760Medical Information: Canada_MedInfo@fresenius-kabi.com |
| Beyfortus, nirsevimab | Solution, 100 mg/1 mL, Intramuscular | United States, Food and Drug Administration, National Drug Code (NDC) 49281-574-15 | Sanofi Pasteur Limited | N/A | September 19, 2024 | October 30, 2024 |
Contact Sanofi Pasteur Limited at 1755 Steeles Avenue West, Toronto, Ontario, Canada, M2R 3T4. Telephone: 1-800-265-7927 |
| Pantoprazol Normogen 40 mg, pantoprazole sodium sesquihydrate | Powder for solution, 40 mg/vial, intravenous | Spain, Spanish Agency for Medicine and Health Products, 85854 | Juno Pharmaceuticals Corp. | N/A | August 22, 2024 | November 1, 2024 | Juno Pharmaceuticals Corp. at: 402-2233 Argentina Road, Mississauga, Ontario, Canada, L5N 2X7 |
| Biltricide, praziquantel | Tablet, 600 mg, oral | United States, Food and Drug Administration, National Drug Code (NDC) 50419-747-01 | Bayer Inc. | N/A | August 16, 2024 | September 30, 2025 | Bayer Inc. 292 Matheson Blvd. E. Mississauga, ON L4W 5R6 Email: Canada.medinfo@bayer.com Phone: 1-800-265-7382 |
| Calcium Chloride / DEMO 10% w/v Solution for Infusion | Solution, 10% w/v, Intravenous | Greece, National Organization for Medicines, 24623/15/2-8-2016 | Juno Pharmaceuticals Corp. | N/A | December 14, 2023 | April 30, 2024 | Juno Pharmaceuticals Corp. 402-2233 Argentia Road, Mississauga, Ontario, L5N 2X7 Canada |
| Cholestyramine for Oral Suspension USP, cholestyramine resin | Powder for suspension, 4 g, oral | United States, Food and Drug Administration, National Drug Code (NDC) 27241-134-36 | Juno Pharmaceuticals Corp. | N/A | March 30, 2024 | March 15, 2025 | Juno Pharmaceuticals Corp.
402-2233 Argentia Road, Mississauga, Ontario, L5N 2X7, Canada |
| Ketamine Hydrochlori de Injection, Ketamine Hydrochlori de | Solution, 50 mg/mL, Intravenous (IV), Intramuscular (IM) |
United Kingdom, UK MHRA, PL 01502/ 0099 | Juno Pharmace uticals Corp | N/A | April 6, 2023 | October 7, 2023 |
Juno Pharmaceuti cal Corp, 402-2233 https://www.junopharm.ca/ |
| Omnipaque 350, Iohexol | Solution, 755 mg/mL, IBP - intravenous, PBP- intravascular,oral, intra-arterial | United States, Food and Drug Administration, National Drug Code (NDC): 0407-1414-72 and 0407-1414-98 |
GE Healthcare Canada Inc. | N/A | August 22, 2022 | February 22, 2023 | Contact GE Healthcare Canada Inc. at: 1919 Minnesota Court Mississauga, ON, Canada L5N 0C9 Telephone: 866-281-7545 |
| Histatrol, histamine phosphate | Solution, 2.75 mg/mL and 0.275 mg/mL, intradermal | United States of America, Food and Drug Administration, NDC #0268-0247-05 (2.75 mg/mL) and NDC #0268-0248-05 (0.275 mg/mL) |
ALK-Abello Pharmaceuticals Inc. | N/A | February 20, 2023 | December 31, 2025 | Contact ALK-Abello Inc. at 151 Brunel Road, Suite 32-35 Mississauga, ON Canada L47 2H6 Tel: 1-289-374-6317 |
| Miostat, Carbachol |
Solution, 0.01%, Intraocular |
United States, US FDA, NDC 0065-0023-15 | Alcon Canada Inc | N/A | February 16, 2023 | April 1, 2023 |
Alcon Canada, Inc. Phone: +1905-826-6700 |
| BSS Sterile Irrigating Solution, balanced salt solution | Solution, 500 mL, Irrigation | United States, Food and Drug Administration, National Drug Code (NDC): 0065-1795-04 |
Alcon Canada Inc. | N/A | February 16, 2023 | June 30, 2023 | Contact Alcon Canada Medical Information at canada.medinfo@Alcon.com or 1-800-613-2245 |
| Omnipaque 300, Iohexol | Solution, 647 mg/mL, intrathecal, intravascular, oral or rectal, intra-arterial, body cavity; IBP - intravenous | United States, Food and Drug Administration, National Drug Code (NDC): 0407-1413-63 and 0407-1413-72 |
GE Healthcare Canada Inc. | N/A | December 22, 2022 | TBD |
Contact GE Healthcare Canada Inc. at: 1919 Minnesota Court Phone: 866-281-7545 |
| Eptifibatide | Solution, 0.75mg/mL & 2mg/mL, Intravenous | United Kingdom, Medicines and Healthcare products Regulatory Agency, PL number: 0.75mg/ml - PL44853/0002; 2mg/mL - PL44853/0003 |
Juno Pharmaceuticals Corp. | TBD, 0.75mg/mL - 6000 units; 2mg/mL – 5000 units | January 23, 2023 | July 20, 2023 |
Contact Juno Pharmaceuticals Corp. at: 402-2233 Argentina Road, Mississauga, Ontario, Canada, L5N 2X7 Phone: 905-829-3838 Fax: 905-829-3810 |
| Visipaque 320, Iodixanol | Solution, 652mg/mL, intra-arterial, intravenous | United States, Food and Drug Administration, National Drug Code NDC: 0407-2223-17, 0407-2223-21 | GE Healthcare Canada Inc. | N/A | August 22, 2022 | February 22, 2023 | Contact GE Healthcare Canada Inc. at: 1919 Minnesota Court Mississauga, ON, Canada L5N 0C9 Telephone: 866-281-7545 |
| Amiodarone Hydrochloride Injection, USP, Amiodarone Hydrochloride | Solution, 50 mg/mL, Intravenous | United States, Food and Drug Administration, National Drug Code (NDC): 0143-9875-01, 0143-9875-25, 0143-9875-10 | Hikma Canada Limited | N/A | November 16, 2022 | January 31, 2023 | Contact Hikma Canada Limited at: 5995 Avebury Road, Suite 804 Mississauga, ON Canada L5R 3P9 Phone: 1-800-656-0793 |
| Prostin VR Pediatric, Alprostadil | Sterile Solution, 500 mcg/mL, intravenous infusion | United States, Food and Drug Administration, NDC 00009-3169-06 | Pfizer Canada ULC | N/A | October 27, 2023 | December 8, 2023 | Contact Pfizer Canada at: 17300 Trans-Canada Hwy., Kirkland, QC H9J 2M5 Telephone: 1-866-723-7111 Fax: 1-855-242-5652 |
| Dexrazoxane for injection, Dexrazoxane | Powder for solution, 250 mg, Intravenous | United States, US FDA, NDC 0143-9247-01 | Hikma Canada Limited | N/A | March 24, 2023 | December 31, 2023 | Hikma Canada Limited, 5995 Avebury Road, Suite 804 Mississauga Ontario Canada L5R 3P9 Phone: 1.800.656.0793 www.hikma.com |
| 0.9% Sodium Chloride Injection USP, Sodium Chloride | Solution, 900 MG / 100 ML, Intravenous | United States, Food and Drug Administration, National Drug Code (NDC): 0338-0049-04 | Baxter Corporation | N/A | August 31, 2022 | March 31, 2023 | Contact Baxter Corporation at: 7125 Mississauga Rd., Mississauga, ON, L5N 0C2 Telephone: 1-888-719-9955 Fax: 1-905-369-6560 |
| Viberzi, eluxadoline | Tablets, 75 & 100 mg, Oral |
United States, Food and Drug Administration, National Drug Code (NDC) 61874-075-60 (75 mg) and NDC 61874-100-60 (100 mg) | AbbVie Corporation | N/A | October 5, 2022 | January 31, 2025 | Contact AbbVie Corporation at: 8401 route Transcanadienne Saint-Laurent, QC H4S 1Z1 |
| Arganova, Argatroban | Solution, 100 mg/mL, Intravenous | France, National Agency for the Safety of Medicine and Health Products, 34009 277 480 0 4 | Sandoz Canada Inc. | 1984195E 2068570B 2095479C 2095481A 2095481D |
October 5, 2022 | November 30, 2023 | Contact Sandoz Canada Inc. at: 110 rue de Lauzon, Boucherville, QC J4B 1E6 Telephone: 1-800-361-3062 |
| 0.9% Sodium Chloride Injection, USP, Sodium Chloride |
Solution, 9mg/mL, Intravenous, Intramuscular or Subcutaneous use |
United States, Food and Drug Administration National Drug Code (NDC): 00409-4888-10 |
Pfizer Canada ULC | N/A | January 28,2022 | March 2, 2022 | Contact Pfizer Canada at: 17300 Trans-Canada Hwy., Kirkland, QC H9J 2M5 Telephone: 1-866-723-7111 Fax: 1-855-242-5652 |
| Actemra, Tocilizumab | Solution, 80 mg/4 mL, Intravenous Use |
Canadian Actemra (Health Canada, DIN: 02350092) in global EFA packaging and labelling (Global Trade Item Number: 07640128015161) |
Hoffmann-La Roche | N/A | February 22, 2021 | June 1, 2022 | Contact Hoffmann-La Roche at: 7070 Mississauga Road Mississauga, ON L5N 5M8 Telephone: 1-888-762-4388 Fax: 1-905-542-5610 |
| Actemra, Tocilizumab | Solution, 200 mg/10 mL, Intravenous Use |
Canadian Actemra (Health Canada, DIN: 02350106) in global EFA packaging and labelling (Global Trade Item Number: 00056090899314) | Hoffmann-La Roche | N/A | February 22, 2021 | June 1, 2022 | Contact Hoffmann-La Roche at: 7070 Mississauga Road Mississauga, ON L5N 5M8 Telephone: 1-888-762-4388 Fax: 1-905-542-5610 |
| Actemra, Tocilizumab | Solution, 400 mg/20 mL, Intravenous Use |
Canadian Actemra (Health Canada, DIN: 02350114) in global EFA packaging and labelling (Global Trade Item Number: 07640128015208) | Hoffmann-La Roche | N/A | February 22, 2021 | June 1, 2022 | Contact Hoffmann-La Roche at: 7070 Mississauga Road Mississauga, ON L5N 5M8 Telephone: 1-888-762-4388 Fax: 1-905-542-5610 |
| Cortef, Hydrocortisone | Tablet, 10 mg, Oral | United States, Food and Drug Administration, National Drug Code (NDC) 0009-0031-01 | Pfizer Canada ULC | N/A | May 18, 2022 | September 30, 2022 | Contact Pfizer Canada at: 7300 Trans-Canada Hwy., Kirkland, QC H9J 2M5 Telephone: 1-866-723-7111 Fax: 1-855-242-5652 |
| Depo-Provera, Medroxyprogesterone Acetate |
Suspension for Injection, 150 mg/mL, Intramuscular |
United States, Food and Drug Administration National Drug Code (NDC) 0009-7376-11 |
Pfizer Canada ULC | N/A | March 31, 2021 | July 20, 2022 | Contact Pfizer Canada at: 17300 Trans-Canada Hwy., Kirkland, QC H9J 2M5 Telephone: 1-866-723-7111 Fax: 1-855-242-5652 |
| Diprivan 10mg/mL, Propofol |
Emulsion, 10mg/mL, Intravenous use |
Italy, Agenzia Italiana del Farmaco 026114025 |
Aspen Pharmacare Inc. | N/A | September 18, 2020 | March 2, 2022 | Contact Aspen Pharmacare Canada Inc. at: 8 - 1155 North Service Road West, Oakville, Ontario L6M 3E3 Telephone: 1-844-330-1213 |
| Disoprivan 1%, Propofol |
Solution, 500mg/50mL (1%), Intravenous use |
Switzerland, Swiss Medic, 47162 076 |
Aspen Pharmacare Canada Inc. | N/A | July 23, 2020 | March 2, 2022 | Contact Aspen Pharmacare Canada Inc. at: 8 - 1155 North Service Road West, Oakville, Ontario L6M 3E3 Telephone: 1-844-330-1213 |
| Erwinase, Erwinia L-asparaginase | Powder for solution, 10,000 IU, Subcutaneous, Intravenous, Intramuscular |
United Kingdom, Medicines and Healthcare products Regulatory Agency, PL44403/0002 |
SteriMax Inc. | W060172, W060517, W061186, W061933, W062155,W065343 |
April 4, 2022 | November 30, 2022 | SteriMax Inc., 2770, Portland Drive, Oakville, ON, L6H 6R4 Phone: +1-800-881-3550 Fax: +1 -877-546-7667 E-mail: medinfo@sterimaxinc.com |
| Fresenius Propoven, Propofol | Emulsion for injection or infusion, 100mL vial - 20mg/mL (2%), Intravenous use |
Austria and Sweden, Inner vial label: M080395 Outer box label: M080396 Package leaflet: M080510 |
Fresenius Kabi Canada Ltd. | N/A | April 16, 2020 | March 2, 2022 | Dear Healthcare Professional Letter |
| Hydralazine Hydrochloride Injection USP, Hydralazine | Sterile Solution, 20mg/mL, Intravenous, Intramuscular | United States, Food and Drug Administration, National Drug Code (NDC) 0517-0901-25 | SteriMax Inc. | N/A | July 11, 2022 | November 1, 2022 | SteriMax Inc., 2770, Portland Drive, Oakville, ON, L6H 6R4 Phone: +1-800-881-3550 Fax: +1 -877-546-7667 E-mail: medinfo@sterimaxinc.com |
| Vigabatrin | Powder, 500mg/sachet, Oral | United States, Food and Drug Administration, National Drug Code (NDC): 43598-697-11, 43598-697-50 | Dr. Reddy's Laboratories Canada Inc. | N/A | September 15, 2023 | June 15, 2024 | Contact: Dr. Reddy's Laboratories Canada Inc. 5580 Explorer Drive, Suite 204, Mississauga, ON L4W 4Y1 Canada |
| Collagenase SANTYL Ointment, Collagenase | Ointment, 250 units/g, Topical | United States, Food and Drug Administration, National Drug Code (NDC): 50484-010-30 | Smith & Nephew Inc. | N/A | September 15, 2023 | March 31, 2025 | Contact Smith & Nephew Inc. at: 2280 Argentina Road Mississauga, Ontario L5N 6H8 Canada https://smith-nephew.com/en-ca/contact-us#ap-cards |
| Levofloxacin Injection in 5% Dextrose, levofloxacin | Injectable Solution, 5 mg/mL, intravenous infusion | United States, Food and Drug Administration, NDCs: 0143-9722-24 (50 mL) 0143-9721-24 (100 mL) 0143-9720-24 (150 mL) |
Hikma Canada Limited | N/A | April 11, 2022 | October 31, 2022 | Contact Hikma Canada Limited at: 5995 Avebury Road, Suite 804 Mississauga, ON Canada L5R 3P9 Phone: 1-800-656-0793 |
| Lorazepam Injection | 4 mg/mL Intramuscular, Intravenous |
United States, Food and Drug Administration, National Drug Code (NDC) 0641-6045-25 | Innomar Strategies inc. on behalf of Hikma Canada Limited | N/A | September 23, 2022 | December 15, 2022 | Contact Hikma Canada Limited at: 5995 Avebury Road, Suite 804 Mississauga, ON L5R 3P9 |
| Moxilen Forte, Amoxicillin trihydrate | Powder for oral suspension, 250 mg/5 mL, Oral | Kosovo, Kosovo Medicines Agency, Renewal Marketing Authorization 2603/16/11/2021 | Juno Pharmaceuticals Corp. | N/A | December 28, 2022 | April 30, 2023 | Contact Juno Pharmaceuticals Corp. at: 402-2233 Argentia Road, Mississauga, Ontario, L5N 2X7, Canada |
| Moxilen Forte, Amoxicillin trihydrate | Powder for oral suspension, 250 mg/5 mL, Oral | Cyprus, Ministry of Health – Pharmaceutical Services, 007277 | Juno Pharmaceuticals Corp. | N/A | December 28, 2022 | March 31, 2024 | Contact Juno Pharmaceuticals Corp. at: 402-2233 Argentia Road, Mississauga, Ontario, L5N 2X7, Canada |
| Oncaspar, Pegaspargase | Solution for Injection or Infusion, 3,750units/5mL, Intravenous, Intramuscular | United States, Food and Drug Administration, National Drug Code (NDC): 72694-954-01 | Servier Canada Inc. | 2227A, 2493A | February 3, 2023 | February 15, 2024 |
Contact Servier Canada Inc. at: Phone: 450-978-9700 Company Communication for Healthcare Professionals: https://multimedia.eservier.com/servierfr-0/documents/171c46e6-1137-4046-8f4c-82e921ab67ff.pdf |
| PEYONA, caffeine citrate | Solution for infusion, intravenous or oral solution, oral | United Kingdom, Medicines and Healthcare products Regulatory Agency, PLGB 08829/0189 | Methapharm Inc. | N/A | November 8, 2022 | December 12, 2022 | Contact Methapharm Inc. at: 81 Sinclair Boulevard, Brantford, ON, N3S 7X6 Tel: 519-751-3602 |
| PrismaSATE BGK4/0/1.2, Multiple Medical Ingredients (CRRT) | Solution, Dialysis, Intravenous Use | United States, Food and Drug Administration License Number K072908 Product Code: 110411 |
Baxter Corporation | N/A | July 12, 2021 | June 30, 2022 | CContact Baxter Corporation at: 7125 Mississauga Rd., Mississauga, ON, L5N 0C2 Telephone: 1-888-719-9955 Fax: 1-905-369-6560 |
| PrismaSATE BK0/3.5 Multiple Medical Ingredients (CRRT) | Solution,Dialysis, Intravenous Use | Mexico, Comisión Federal para la Protección contra Riesgos Sanitarios, License number: 2369C2009 SSA Product Code: 105353 |
Baxter Corporation | N/A | July 12, 2021 | June 30, 2022 | Contact Baxter Corporation at: 7125 Mississauga Rd., Mississauga, ON, L5N 0C2 Telephone: 1-888-719-9955 Fax: 1-905-369-6560 |
| PrismaSol BGK4/0/1.2, Multiple Medical Ingredients (CRRT) | Solution,Dialysis, Intravenous Use | United States, Food and Drug Administration NDC 24571-114-06 | Baxter Corporation | N/A | July 12, 2021 | June 30, 2022 | Contact Baxter Corporation at: 7125 Mississauga Rd., Mississauga, ON, L5N 0C2 Telephone: 1-888-719-9955 Fax: 1-905-369-6560 |
| PrismaSol BGK4/2.5 Multiple Medical Ingredients (CRRT) | Solution,Dialysis, Intravenous Use | United States, Food and Drug Administration NDC: 24571-105-06 |
Baxter Corporation | N/A | July 12, 2021 | June 30, 2022 | Contact Baxter Corporation at: 7125 Mississauga Rd., Mississauga, ON, L5N 0C2 Telephone: 1-888-719-9955 Fax: 1-905-369-6560 |
| Propofol Injectable Emulsion, USP, Propofol | Emulsion, 1000 mg per 100 mL (10 mg/mL), Intravenous |
United States, Food and Drug Administration NDC 25021-608-51 |
Omega Laboratories Limited | N/A | April 28, 2021 | March 2, 2022 | Contact Omega Laboratories Limited at: 11177 Hamon Street Montreal, Quebec Canada, H3M 3E4 |
| Propylthiouracil 50mg Tablets; Propylthiouracil |
Tablet, 50mg, Oral use |
United Kingdom, Medicines and Healthcare Products Regulatory Agency, PL 00042/0205 PA 1888-2-1 |
Accelera Pharma Canada | 61096F |
August 21, 2020 | June 1, 2022 | Contact Accelera Pharma Canada at: 210B-219 Dufferin Street Toronto, ON M6K 3J1 Telephone: 1-289-208-4191 |
| Prostin VR Pediatric, Alprostadil | Sterile Solution, 500 mcg/mL, intravenous infusion | United States, Food and Drug Administration, NDC 00009-3169-06 | Pfizer Canada ULC | N/A | March 7, 2022 | April 29, 2022 | Contact Pfizer Canada at: 17300 Trans-Canada Hwy., Kirkland, QC H9J 2M5 Telephone: 1-866-723-7111 Fax: 1-855-242-5652 |
| PTU™, Propylthiouracil |
Tablet, 50mg, Oral use |
Australia, Therapeutic Goods Administration, AUST R 13313 |
Phebra Canada Inc. | Lot: 801460, 848726, 883345, 876591, 889241, 897976 | June 18, 2020 | June 1, 2022 | Company Communications for Healthcare Professionals |
| Sabril, vigabatrin | Powder, 500 mg/sachet, Oral | United States, Food and Drug Administration, National Drug Code (NDC): 67386-211-65 | Lundbeck Canada Inc. | N/A, 2,000 units | September 26, 2022 | February 28, 2023 |
Contact Lundbeck Canada Inc. at: 2600 Alfred-Nobel Suite 400, Phone: 514-844-8515 Fax: 514-844-5495 |
| TECHNETIUM TC 99M TSC, Sodium Thiosulfate Pentahydrate |
Powder for Solution, Kit, 2mg/vial, Oral, Intravenous, Intraperitoneal |
United States, Food and Drug Administration, National Drug Code (NDC): 45567-0030-1 |
GE Healthcare Canada Inc. | N/A | July 13, 2022 | August 12, 2022 | Contact GE Healthcare Canada Inc. at: 1919 Minnesota Court Mississauga, ON, Canada L5N 0C9, Phone: 866-281-7545 |
| Magnesium Sulfate 50% w/v Solution for Injection, Magnesium Sulfate (heptahydrate) | Solution, 500 mg/mL (5g/10mL), Intravenous, Intramuscular | United Kingdom, Medicines and Healthcare products Regulatory Agency, MIA 1883 | SteriMax Inc. | N/A | October 19, 2022 | November 30, 2022 | Contact SteriMax Inc. at: 2770, Portland Drive, Oakville, ON, L6H 6R4 Phone: +1-800-881-3550 Fax: +1 -877-546-7667 E-mail: medinfo@sterimaxinc.com |
| Rylaze CRISANTASPASE |
10 mg/0.5 mL Solution for intramuscular injection |
United States, US FDA, NDC 68727-900-03 | Jazz Pharmaceuticals Canada | COM6, COM7 | October 19, 2022 | February 28, 2023 | Jazz Pharmaceuticals Canada, Inc. 4080 Confederation Parkway Suite 602 Mississauga, Ontario L5B 0G1 Main Line: 647-946-8801 |
| TPOXX, tecovirimat | Capsule, 200 mg, Oral | United States, Food and Drug Administration, National Drug Code (NDC) 50072-200-42 |
Innomar Strategies Inc. | N/A | July 25, 2022 | December 31, 2022 | Contact SIGA Technologies, Inc. at 1-888-899-3472 |
| White-Faced Hornet Venom Protein, White-Faced Hornet Venom Protein | Powder for Solution, 550 MCG/VIAL, Subcutaneous | United States, Food and Drug Administration, National Drug Code (NDC) 65044-9941-5 |
Omega Laboratories | N/A | August 4, 2022 | October 31, 2024 | Contact Omega Laboratories at: 11177 Hamon Street, Montreal, QC H3M 3E4 Telephone: 1.800.363.0584 Fax: (514) 339.1407 Email: info@omegalabs.ca |
| Yellow Jacket Venom Protein, Yellow Jacket Venom Protein | Powder for Solution, 550 MCG/VIAL, Subcutaneous | United States, Food and Drug Administration, National Drug Code (NDC) 65044-9944-5 |
Omega Laboratories | N/A | August 4, 2022 | January 31, 2023 | Contact Omega Laboratories at: 11177 Hamon Street, Montreal, QC H3M 3E4 Telephone: 1.800.363.0584 Fax: (514) 339.1407 Email: info@omegalabs.ca |
| Zepzelca, lurbinectedin | Sterile powder, 4mg/vial, Intravenous Infusion | United States, Food and Drug Administration, National Drug Code (NDC): 68727-712-01 | Jazz Pharmaceuticals Canada Inc. | 1888484, 1000 vials | April 25, 2022 | June 30, 2022 | Contact Jazz Pharmaceuticals Canada Inc. at: 4080 Confederation Parkway, Suite 602, Mississauga, ON, Canada L5B 0G1 Phone: 647-946-8801 Fax: 647-946-8802 |
| Ketamine HCl Solution for Injection, Ketamine Hydrochloride |
Solution, 500 mg/10 ml, Intravenous (IV), Intramuscular (IM) |
Portugal, Infarmed, PL 01502/ 0099 | Hikma Canada Limited | N/A | May 19, 2023 | October 7, 2023 |
Contact Hikma Canada Limited at: 5995 Avebury Road, Suite 804 |
| Glucagon Injection, glucagon | Kit, 1 mg/vial, intramuscular, intravenous, subcutaneous |
United States, Food and Drug Administration, National Drug Code (NDC): 0548-5850-00 |
Amphastar Pharmaceuticals Inc. | N/A | May 19, 2023 | December 31, 2025 |
Contact Amphastar Pharmaceuticals Inc. at: 11570 6th Street, |
| Dipyridamole Injection, USP, dipyridamole | Solution, 5 mg/mL, Intravenous | United States, Food and Drug Administration, National Drug Code (NDC): 0641-2569-41 (single vial) 0641-2569-44 (5-vial pack) |
Hikma Canada Limited | N/A | June 30, 2023 | January 31, 2024 | Contact Hikma Canada at 1-800-656-0793 or emailing Canada_drugsafety@hikma.com |
| APO-go Pen, Apomorphine Hydrochloride | Solution, 10 mg/mL, Subcutaneous | United Kingdom, Medicines and Healthcare Products Regulatory Agency, PL 04483/0073 | Accuristix | N/A | December 11, 2023 | December 31, 2024 | Accuristix 100 Vaughan Valley Boulevard Vaughan, Ontario, Canada L4H 3C5 905-829-9927 |
| Cisatracurio Hikma 2 mg/ml, Cisatracurium Besylate | Solution, 2mg/mL, Intravenous | Italy, Italian Drug Agency (AIFA), 044195093 | Hikma Canada Limited | N/A | March 8, 2024 | May 15, 2024 |
Contact Hikma Canada Limited at: |
| Colesevelam Hydrochloride Tablets, colesevelam hydrochloride | Tablet, 625 mg, oral | United States, Food and Drug Administration, National Drug Code (NDC) 68462-433 | Glenmark Pharmaceuticals Canada Inc. | N/A | March 13, 2024 | June 30, 2024 | Glenmark Pharmaceuticals Canada Inc. 1600 Steeles Avenue West, Suite 407, Concord, Ontario L4K 4M2 |
| Imunovir, Inosine pranobex | Tablet, 500 mg, oral | United Kingdom, Medicines and Healthcare products Regulatory Agency, PL 39972/0001 | Kora Healthcare Canada Inc | N/A | May 3, 2024 | December 31, 2024 | Contact Kora Healthcare Canada at: 1155 North Service Road West, Oakville, Ontario, L6M 3E3 Telephone: 1-778-807-9718 Fax: 1-778-381-5695 |
| Carbamazepine extended release USP, Carbamazepine | Tablets, 200 mg, oral | United States, Food and Drug Administration, National Drug Code (NDC): 50742-0258-01 | Septa Pharmaceuticals Inc. | N/A | May 31, 2024 |
December 15, 2024 |
Contact Septa Pharmaceuticals Inc.; 7035 Maxwell Road, Unit 2 Mississauga, ON L5S 1R5 |
| Carbamazepine extended release USP, Carbamazepine | Tablets, 400 mg, oral |
United States, Food and Drug Administration, National Drug Code (NDC): 50742-0259-02 |
Septa Pharmaceuticals Inc. | N/A | May 31, 2024 |
December 15, 2024 |
Contact Septa Pharmaceuticals Inc.; 7035 Maxwell Road, Unit 2 Mississauga, ON L5S 1R5 |
| Chloroprocaine Hydrochloride Injection, USP, Chloroprocaine Hydrochloride, USP | Solution, 20 mg/mL, Infiltration | United States, Food and Drug Administration, National Drug Code (NDC) 0143-9209-10 | Hikma Canada Limited | N/A | July 29, 2024 | December 31, 2024 |
Contact Hikma Canada Limited at: 5995 Avebury Road, Suite 804 Phone: 1-800-656-0793 |
| Marcain – Adrenalin, Bupivacaine hydrochloride and Epinephrine |
Solution, 5mg/ml/5mcg/ml, Block/Infiltration, epidural |
Denmark, Danish Medicines Agency, 10213 | Aspen Pharmacare Canada | N/A | July 29, 2024 | September 30, 2024 |
Contact Aspen Pharmacare Canada Inc. at: 8 - 1155 North Service Road West, Telephone: 1-844-330-1213 |
| Epinephrine Injection USP, Epinephrine | Solution, 1 mg/10 mL, Intravenous | United States of America, Food and Drug Administration, NDC #76329-3318-1 | Amphastar Pharmaceuticals, Inc. | N/A | August 8, 2024 | June 30, 2025 |
Amphastar Pharmaceuticals Inc. 11570 6th Street, |
|
Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL), Doxorubicin Hydrochloride |
Sterile aqueous suspension, 2 mg/mL, For intravenous infusion only after dilution | United States, United States, Food and Drug Administration, National Drug Code (NDC) 47335-049-40 | Taro Pharmaceuticals Inc. | N/A | October 4, 2024 | January 31, 2025 |
Taro Pharmaceuticals Inc. |
| Methotrexate for Injection, USP 50mg/ml (Preservative-Free) | Lyophilized Powder for Solution, 1 g/Vial, for Intramuscular, Intravenous, Intraarterial or Intrathecal routes. | United States of America, US FDA, 63323-122-50 |
Fresenius Kabi Canada Ltd. | N/A | October 17, 2024 | January 15, 2025 |
Contact Fresenius Kabi Canada Inc. at: or Address: |
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