Nasal Spray Recalled by Health Canada Due to Bacterial Risk

Health Canada has issued a recall for two batches of APO-Mometasone nasal spray, a product used to treat allergy symptoms, sinusitis and nasal polyps, because of a possible bacterial contamination. The recall affects the products with expiry dates in September or October 2025, which may contain Burkholderia cepacia complex (Bcc), a group of bacteria that can cause serious infections, especially in people with weakened immune systems. In this article, we will explain the details and implications of the recall, and the actions and precautions that consumers should take.

The Product: APO-Mometasone Nasal Spray

APO-Mometasone nasal spray is a prescription drug that contains mometasone furoate, a corticosteroid that reduces inflammation and swelling in the nasal passages. The product is used to treat various conditions, such as:

  • Allergic rhinitis, a type of allergy that causes sneezing, itching, runny nose and congestion.
  • Sinusitis, an inflammation of the sinuses that causes pain, pressure, fever and nasal discharge.
  • Nasal polyps, benign growths in the nasal lining that can block the air flow and cause breathing difficulties.
Nasal Spray
Nasal Spray

The product is sold in a white plastic bottle with a pump spray and a blue cap, and has the following information on the label:

  • DIN: 02411523
  • Lot number: 9G04 or 9G05
  • Expiry date: 09/2025 or 10/2025

The product is manufactured by Apotex Inc., a Canadian pharmaceutical company, and is distributed by pharmacies across the country.

The Problem: Bacterial Contamination

The problem with the recalled product is that it may be contaminated with Bcc, a group of bacteria that are commonly found in soil and water, and can cause various infections in humans and animals. Bcc can affect different parts of the body, such as the lungs, skin, blood, urinary tract and eyes, and can cause symptoms such as:

  • Fever, chills, fatigue and malaise.
  • Cough, shortness of breath, chest pain and sputum production.
  • Skin rash, ulcers, abscesses and nodules.
  • Urinary tract infection, burning sensation, frequency and urgency.
  • Eye infection, redness, pain, discharge and blurred vision.

Bcc poses a minimal risk to healthy people, who may not experience any symptoms or only mild ones. However, Bcc can be dangerous for people who have chronic lung diseases, such as cystic fibrosis or bronchiectasis, or who have weakened immune systems, such as those who have HIV, cancer, diabetes, organ transplants or are taking immunosuppressive drugs. In severe cases, Bcc can lead to bloodstream infections that may result in sepsis, a life-threatening condition that causes organ failure and death. Bcc is also often resistant to common antibiotics, making it difficult to treat.

The Recall: Health Canada’s Action and Advice

The recall was initiated by Apotex Inc. after it received a complaint from a consumer who reported finding a black substance in the nasal spray bottle. The company conducted an investigation and confirmed the presence of Bcc in the product. The company then notified Health Canada, which issued the recall on February 19, 2024.

Health Canada advises consumers who have the recalled product to stop using it and return it to their pharmacy for disposal. Health Canada also advises consumers to consult their health care provider if they have used the product and have experienced any symptoms or adverse reactions, or if they have any questions or concerns about their health.

Health Canada also informs the health care professionals who prescribe or dispense the product to contact their patients who may have the recalled product and advise them to stop using it and return it to the pharmacy. Health Canada also advises the health care professionals to monitor their patients for any signs or symptoms of infection, and to report any adverse events to Health Canada.

Health Canada says that it will continue to monitor the situation and will take further action if necessary. Health Canada also says that it will update the public if any new information becomes available.

A Precautionary and Protective Measure

The recall of APO-Mometasone nasal spray by Health Canada is a precautionary and protective measure, which aims to prevent and reduce the risk of infection and harm to the consumers who may have the contaminated product. The recall affects only two batches of the product, which have specific lot numbers and expiry dates, and does not affect other batches or products that contain mometasone furoate. The recall is based on the evidence and information provided by the manufacturer, Apotex Inc., and is supported by the scientific and medical expertise of Health Canada. The recall is also communicated and coordinated with the relevant stakeholders, such as the pharmacies, the health care professionals and the public, to ensure the effective and efficient implementation of the recall.

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