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

FAQs

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

The affected APO-Mometasone sprays are from lot numbers TX5343 and TZ2586 and have expiry dates of September and October 2025. Health Canada says anyone who has the recalled sprays should return them to a local pharmacy for proper disposal.

Issue. Apotex Inc. is recalling two lots of APO-Mometasone nasal spray due to possible bacterial contamination with Burkholderia cepacia complex (Bcc).

The nasal spray has been found to contain small glass particles which could block the actuator and impact the functionality of the pump. There is a potential for patients to be exposed to the glass particles and mechanical irritation cannot be ruled out.

The recalled lots are TX5343 and TZ2586, which have expiry dates of Sep 2025 and Oct 2025, respectively.

In clinical trials with fluticasone propionate administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has occurred. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of FLONASE Nasal Spray.

Like all medicines, mometasone can cause side effects but many people have no side effects or only minor ones. With mometasone nasal spray, if you're not using high doses for a long time, very little medicine is absorbed into the rest of your body, so it's not likely to give you serious side effects.

Official answer. Over-the-counter (OTC) Flonase Allergy Relief is exactly the same strength, dose and medicine as prescription Flonase - fluticasone 0.05 mg / spray. The prescription branded Flonase product is now discontinued in the U.S., but OTC Flonase products, generics, and store brands are still available.

Conclusion: Nasal steroid spray bottle tips can become contaminated with sinonasal cavity bacteria.

The bottom line

OTC steroid and antihistamine nasal sprays work best for treating allergy symptoms. Common examples include Flonase Allergy Relief (fluticasone), Nasacort Allergy 24 Hour (triamcinolone), and Astepro Allergy (azelastine). They're safe for both adults and children to use every day.

You may be tempted to stop using FLONASE when you start to feel better. It is important to keep using FLONASE daily as long as allergens bother you, like pollen, mold, dust, or pet dander—so you'll continue to enjoy relief from your symptoms.

Is there a class action lawsuit against Flonase? ›

The lawsuit claims that the seller of Flonase violated state laws by delaying the availability of generic versions of Flonase. The seller is SmithKline Beecham Corporation doing business as GSK. GSK denies it has done anything wrong, but has agreed to settle the claims in the lawsuit for a total of $35 million.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Biomic Sciences Issues Voluntary Nationwide Recall of ION* Sinus Support, ION* Sinus, and Restore Sinus Spray Products Due to Microbial Contamination. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service.

In April 2024, recalls and notifications for medicines were issued on: Class 3 Medicines Recall: Bristol-Myers Squibb Pharmaceuticals Limited, OPDIVO 10 mg/mL concentrate for solution for infusion (nivolumab), EL(24)A/11. Issued 4 April 2024.

Warnings and precautions

Long-acting β adrenoreceptor agonists (LABAs) are subject to a boxed warning against the possibility of an increased risk of asthma-related death.

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.

Talk to your doctor if you have concerns. Infections: Corticosteroids such as mometasone nasal spray may worsen existing infections, mask the signs of infection, and cause new infections. If you use this medication for several months or longer, your doctor will monitor you periodically for signs of infection.

Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems. A very serious allergic reaction to this drug is rare.

Contamination is a common aspect of nasal saline irrigations. Product contamination is a major risk factor for outbreaks of infectious diseases.