Apotex recalls one lot of its Apo-Nitroglycerin sublingual spray because of potential device malfunction

Starting date:
September 1, 2017
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-64376

Issue

Health Canada is advising Canadians that Apotex Inc. is voluntarily recalling one lot (lot 6G07) of its Apo-Nitroglycerin sublingual (under the tongue) spray (0.4 mg/metered dose) as the spray pump may malfunction and not deliver the drug.

Nitroglycerin is a drug used to relieve acute attacks of angina (chest pain). The pump is intended to deliver the drug by spraying it under the tongue. Patients experiencing angina who do not receive nitroglycerin could be at risk of suffering a heart attack.

Who is affected

  • Consumers who have bought or used the affected product.

Affected product

Product Strength DIN Size / Format Lot Number Expiry
(MM/YYYY)
Apo-Nitroglycerin,
(nitroglycerin sublingual spray)
0.4mg/metered dose 02393433 200 metered doses in a bottle 6G07 01/2019

What consumers should do

  • Return one of your Apo-Nitroglycerin units from the affected lot to a pharmacy and request a replacement product.
  • Consult your health care professional about all available alternative products. If a replacement is not available, ask your healthcare professional about a suitable therapy for angina control.   
  • If you have questions or concerns about the recall, contact Apotex Inc. via Stericycle (which is managing the recall on behalf of Apotex Inc.) by calling 1-855-215-5004 or by email at apotex8476@stericycle.com.
  • Know that you should always have a spare pump spray or another suitable alternative therapy for angina management readily available for use in case your current pump runs out of medication or doesn’t work properly.
  • Report adverse events to health products to Health Canada by calling toll-free at 1‑866‑234‑2345, or by reporting online, by mail or by fax.
  • Report complaints about health products to Health Canada by calling toll-free at 1‑800‑267‑9675, or complete an online complaint form.

What Health Canada is doing

Health Canada is monitoring the recall and the company’s implementation of any necessary corrective and preventative actions. If new safety information is identified, Health Canada will take appropriate action and inform Canadians.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

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