Health Canada recalls nasal spray over possible bacterial contamination (2024)

The effects of the bacteria can range from no symptoms at all to serious infections.

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Montreal Gazette

Published Feb 19, 2024Last updated Feb 20, 20241 minute read

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Health Canada recalls nasal spray over possible bacterial contamination (1)

Health Canada has issued a recall for two lots of APO-Mometasone nasal spray over a possible bacterial contamination.

The product in question — used to treat allergy symptoms, sinusitis and nasal polyps — is “mometasone furoate aqueous nasal spray” or “50 mcg/metered spray” with expiry dates in September or October 2025.

Apotex Inc. recalled the items over possible contamination with Burkholderia cepacia complex, a group of bacteria Health Canada described as posing minimal risk to healthy people.

“However, children, those with chronic lung diseases, people who are pregnant, seniors and those with a weakened immune system may be at a higher risk of illness,” the agency said.

It added that the effects of the bacteria can range from no symptoms at all to serious infections.

“In severe cases, Bcc can lead to bloodstream infections that may result in sepsis … and death,” Health Canada said. “Bcc is often resistant to common antibiotics. People experiencing persistent or worsening symptoms, such as fevers, or facial pain or pressure, should seek medical attention.”

The agency suggested those with a recalled product return it to a local pharmacy for disposal.

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Health Canada recalls nasal spray over possible bacterial contamination (4)

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Health Canada recalls nasal spray over possible bacterial contamination (2024)

FAQs

Can bacteria grow in nasal spray? ›

Results. Bacterial growth was present in 18 (907%) of the spray group and in 3 (157%) of the drops group (P <. 005). The bacterial counts varied from 102 to 105 and did not differ between the patient groups or between the bacterial isolates.

Is Apo mometasone nasal spray recalled due to potential bacteria contamination? ›

Health Canada is advising that Apotex is recalling two lots of mometasone furoate aqueous nasal spray (APO-Mometasone) due to possible bacterial contamination with Burkholderia cepacia complex (Bcc). The recalled lots are TX5343 and TZ2586, which have expiry dates of Sep 2025 and Oct 2025, respectively.

Can nasal spray be contaminated? ›

Nasal saline irrigations (NSIs) are very common and frequently used for patients with upper respiratory infections and allergic rhinitis. Unfortunately, contamination is a vulnerability and although it does not always lead to an infection, the ability for bacteria to contaminate these products is concerning.

What nasal sprays are banned? ›

It is illegal in the UK to sell nasal sprays or injectables made with "melanotan-2", an artificial hormone that can accelerate tanning. The unlicensed drug is dangerous, dermatologists say, and users should stop immediately. And there is evidence the untested products may be linked to skin cancer.

Why was FLONASE taken off the market? ›

The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump.

How do you clean bacteria out of your sinuses? ›

Nasal irrigation, also known as sinus rinsing, is the practice of moving a saline (saltwater) solution through your nasal passages to clear out mucus and flush out debris and allergens. Irrigation devices, such as neti pots, squeeze bottles and rubber nasal bulbs, push the water through one nostril and out the other.

What kills bacteria in nose? ›

Antibiotics to kill the infecting bacteria.

How do you know if you have bacteria in your nose? ›

Bacterial and viral sinusitis

If you have a runny nose, stuffy nose and facial pain that don't go away after ten days, you might have bacterial sinusitis. Your symptoms may seem to improve but then return and are worse than the initial symptoms.

Can Flonase cause bacterial infections? ›

You may get infections more easily while using this medicine. Tell your doctor right away if you have been exposed to someone with chickenpox or measles. Also tell your doctor if you develop white patches or sores in your nose while you are using this medicine. This could be symptoms of a candida or yeast infection.

Is mometasone nasal spray bad? ›

Very few people have serious side effects when using mometasone nasal spray. You're more likely to have a serious side effect if you use high doses of mometasone for more than a few months.

What is the warning for nasal spray? ›

Do not use more often, use more sprays, or use longer than directed because doing so may increase the risk of side effects. Also, do not use this medication for more than 3 days or it may cause a condition called rebound congestion.

Is there a safe nasal spray? ›

Over-the-counter (OTC) steroid and antihistamine nasal sprays work best to treat allergy symptoms. Flonase Allergy Relief (fluticasone), Nasacort Allergy 24 Hour (triamcinolone), and Astepro Allergy (azelastine) are common examples. They're safe for both adults and children for daily use.

Can bacteria live in saline solution? ›

For most organisms, the growth was even better than the one observed in nutrient-containing solution. Conclusions: The 0.9% saline solution can support significative growing of potentially pathogenic bacteria. We recommend a strict compliance to the good nursing standards when handling this kind of solutions.

What nasal spray not to use? ›

Nasal sprays containing either oxymetazoline or phenylephrine are the rebound congestion-inducing nasal sprays to use with caution. If a nasal spray contains either of these active ingredients, be sure to use only as directed on the label — three days or less.

What major nasal decongestant was recalled? ›

CDC has been notified of a voluntary recall of over-the-counter oxymetazoline HCl 0.05% nasal spray because of intrinsic contamination with Burkholderia cepacia complex. The nasal spray is distributed as "Major Twice-A-Day 12 Hour Nasal Spray." The manufacturer (Propharma Inc., Miami, Florida) has recalled lot no.

Is there a recall on Ocean Saline Nasal Spray? ›

Valeant Pharmaceuticals is voluntarily recalling Ocean Saline Nasal Spray 1.5 fl. oz. and 3.5 fl. oz.

Is there a nasal spray that is safe to use everyday? ›

Nasal antihistamine sprays (Asteline®, Patanase®, Dymista®, etc) are also safe to use on a daily basis and work by blocking the effects of allergens in the nasal lining.

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