September 1, 2017
For Immediate Release
VOLUNTARY NATIONWIDE RECALL: ONE LOT OF APO-NITROGLYCERIN (Nitroglycerin Sublingual Spray) Apotex Standard, 0.4MG/METERED DOSE DUE TO POSSIBILITY OF NON-SPRAYING PUMP
Toronto, Ontario: Apotex Inc. announced today that it is conducting a voluntary nationwide recall of one lot of APO-NITROGLYCERIN (Nitroglycerin Sublingual Spray) Apotex Standard, 0.4MG/METERED DOSE, UPC number 771313217279 and DIN number 02393433 to the Wholesalers, Distributors, Retailers, and Patients level. The impacted lot of APO-NITROGLYCERIN (Nitroglycerin Sublingual Spray) Apotex Standard, 0.4MG/METERED DOSE may contain a non-spraying pump.
A non-spraying pump will result in lack of administration of nitroglycerin to the patient. The potential outcome is inadequate management of angina control which could result in a heart attack.
The product is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. For further details, please refer to the package insert. The product is packaged as 200 metered doses in a bottle. The affected APO-NITROGLYCERIN (Nitroglycerin Sublingual Spray) Apotex Standard, 0.4MG/METERED DOSE lot is as follows:
The product can also be identified by UPC 771313217279 and DIN 02393433. The impacted lot was distributed nationwide in the Canada to wholesalers and distributors by Apotex between March 31, 2017 and June 23, 2017.
Apotex will notify impacted direct account customers by sending the recall notification letter by UPS Express (international) service and is arranging for return of the impacted product lot.
Patients who have received the impacted lot of APO-NITROGLYCERIN (Nitroglycerin Sublingual Spray, 0.4mg / metered dose) should return the product to a pharmacy for replacement. Additionally, patients/consumers may contact Apotex Inc. via Stericycle by calling at 1-855-215-5004 or by email firstname.lastname@example.org if they have any question about the recall.
To report a suspected adverse reaction associated with the use of APO-NITROGLYCERIN (Nitroglycerin Sublingual Spray,0.4mg / metered dose) patients may contact Apotex by calling 1-800-667-4708 (select prompt 2), by email at email@example.com or by fax at 1-866-429-9133 or 416-401-3819.
Patients may also report any suspected adverse reactions associated with the use of health products to Health Canada by calling toll free at 1-866-234-2345 or by visiting MedEffect Canada's Web page on Adverse Reaction Reporting https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html for information on how to report online, by mail or by fax.
Apotex is the 7th largest generic pharmaceutical company globally (according to IMS Health) with more than 11,000 employees worldwide. With its worldwide manufacturing sites, Apotex can produce up to 25 billion dosages per year. It produces 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.