Public advisory

Shortage of Nitroglycerin Sprays and Tablets in Canada

Last updated

Summary

Product
Nitroglycerin 0.4 MG/ACT sprays and Nitrostat 0.3mg/0.6mg sublingual tablets (added on May 10, 2023)
Issue
Health products - Supply
What to do

Speak with your healthcare professional about how best to manage any impact of this shortage. Obtain only the amount you need. Keep expired product and check the table below to determine whether the expiry date of your product has been extended.

Affected products

Company Product
Mylan Mylan-Nitro Sublingual Spray (DIN 02243588)
Sandoz RHO-Nitro Pumpspray (DIN 02238998)
Sanofi Nitrolingual Pumpspray (DIN 02231441)
BGP Pharma Nitrostat Sublingual Tablets 0.3 mg (DIN 00037613) and 0.6 mg (DIN 00037621) - added on May 10, 2023

Issue

UPDATE: November 10, 2023 – Extended Shortage of Mylan’s Nitroglycerin Spray

Mylan is reporting ongoing supply issues with an unknown resolution date for its shortage of nitroglycerin 0.4 MG/ACT spray.

Health Canada, together with its partners, is continuing to look at ways to conserve existing supply, expedite resupplies to hospitals and pharmacies, and access foreign-authorized supply or alternatives, where possible.

To help mitigate this shortage, on November 6, 2023, Health Canada authorized the importation and sale of UK-authorized nitroglycerin spray from Juno Pharmaceuticals Canada. The company is working to bring supply into Canada and to make it available as soon as possible.

May 10, 2023 – Shortage of Nitroglycerin Tablets

Canada is experiencing a shortage of nitroglycerin tablets due to an increase in demand caused by the nitroglycerin spray shortage. Nitroglycerin tablets are placed under the tongue and are used to treat pain during episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart).

Together with its partners, Health Canada is looking at ways to conserve existing supply, expedite resupplies to hospitals and pharmacies, and access foreign-authorized supply or alternatives, where possible.

Original Advisory: March 17, 2023 - Shortage of Nitroglycerin Sprays in Canada

Canada is experiencing a shortage of nitroglycerin 0.4 MG/ACT sprays due to supply issues with the raw materials used to make the sprays as well as an increase in demand.

Nitroglycerin sublingual spray is applied under the tongue and is used to treat pain during episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Nitroglycerin spray is a fast-acting medication, used as needed and is typically used in addition to other medication to treat angina.

Availability of this medication in hospitals and community pharmacies is expected to be limited during the spring. Health Canada is leading work with provincial and territorial governments, manufacturers and stakeholders across the supply chain and healthcare system, including the Canadian Pharmacists Association, the Canadian Cardiovascular Society and the Heart & Stroke Foundation. Together with its partners, Health Canada is looking at ways to conserve existing supply, expedite resupplies to hospitals and pharmacies, and access foreign-authorized supply or alternatives, where possible.

One way to conserve existing supply is the extension of product expiry dates when manufacturers can provide evidence to support such extensions. Certain extensions have already been granted and Health Canada  is asking people to:

  • only obtain what they need from their pharmacy;
  • keep expired product; and
  • check the chart below to confirm which product(s) can be used beyond their Original (Printed) Expiry Date.

Nitroglycerin spray is an important and widely used product. Health Canada recognizes that this shortage is concerning for people who use it to treat pain from angina.

Health Canada is also evaluating the available supply of tablets, which may be a potential alternative for some people.

Products with Approved Extended Expiry Dates

In response to the shortage Health Canada requested that manufacturers determine if certain products could be safely used beyond their printed expiry. Health Canada reviews the information to ensure that the product is safe and will work beyond the printed expiry date. Products with extended expiry dates will be listed below. The chart will be updated as information becomes available.

To determine if a product has an Extended Expiry Date, people should verify whether the Lot Number and Printed Expiry Date on the bottle correspond to any of the lots listed in the chart below. Please see reference image for assistance. People may also wish to seek the assistance of a healthcare professional, such as a pharmacist, to verify. Products should NOT be consumed beyond their Extended Expiry Date listed below.

Product Name Lot Number Original (Printed) Expiry Date Extended Expiry Date
Mylan-Nitro Sublingual Spray (DIN: 02243588) 9F715 06/2022 06/2023
Mylan-Nitro Sublingual Spray (DIN: 02243588) 9F717 06/2022 06/2023
Mylan-Nitro Sublingual Spray (DIN: 02243588) 0B847 02/2023 02/2024
Mylan-Nitro Sublingual Spray (DIN: 02243588) 0B853 02/2023 02/2024
Mylan-Nitro Sublingual Spray (DIN: 02243588) OF904 06/2023 06/2024
Mylan-Nitro Sublingual Spray (DIN: 02243588) OG910 07/2023 07/2024
Mylan-Nitro Sublingual Spray (DIN: 02243588) 0H919 08/2023 08/2024

Mylan-Nitro Sublingual Spray

If you have questions or concerns about this shortage, speak to a health care professional, such as your doctor or pharmacist.

Manufacturers post information about shortages and their expected end date on drugshortagescanada.ca.

Any adverse health product event should be reported to Health Canada.

Additional information

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products - Drugs
Companies
Published by
Health Canada
Audience
General public
Health professionals
Identification number
RA-73344
Media and public enquiries

Health Canada
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media@hc-sc.gc.ca

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