Small particles of glass are to blame for the recall of a widely used fluticasone nasal spray that treats symptoms of hay fever in children.
The nasal spray, known by its brand name Fluticasone Propionate Nasal Spray USP and manufactured by Apotex Corp., of Weston, Fla., was pulled voluntarily from the market by the company, which said the glass particles could clog the bottle and cause it to malfunction and, more importantly, abrade the inside of the nose. The U.S. Food & Drug Administration (FDA) said the issue was detected via a complaint.
Glass Particles Found in Spray Bottle
“The glass particles could block the actuator and impact the functionality of the pump,” the FDA said in a safety alert titled “Fluticasone Propionate Nasal Spray by Apotex Corp: Recall – Due to Potential for Small Glass Particles.” “There is a potential for patients to be exposed to the glass particles and mechanical irritation cannot be ruled out. Local trauma to the nasal mucosa might occur with use of the defective product.”
With the exception of the complaint, Apotex Corp. has not been made aware of any other adverse events as a result of the recall.
“Patients, wholesalers, retailers, hospitals or institutions with Lot# NJ4501 and an expiration date of July 2020, should stop use and distribution of the remaining units and quarantine immediately,” according to the safety alert. “Healthcare Professionals in your organization should be informed of this recall.”
Fluticasone Widely Used for AllergiesFluticasone Propionate Nasal Spray USP is for patients between the ages of 4 and 17 who suffer from seasonal allergies, sinus pain, sneezing and a stuffy nose. The drug also helps with itchy, watery eyes. It is a corticosteroid. WebMD explains its uses:
“The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or use this drug more often or for longer than directed. Your condition will not improve any faster, and your risk of side effects will increase. You may be directed to start with a higher dose of this drug for the first several days until you have begun to feel better, then decrease your dose. Children may need to use this drug for a shorter amount of time to lower the risk of side effects. If a child is using the over-the-counter product, read the package information to see how long he / she should use it and when you should check with the doctor.”
WebMD notes that the drug does not relieve symptoms immediately.
“You may feel an effect as soon as 12 hours after starting treatment, but it may take several days before you get the full benefit. If your condition does not improve after 1 week, or if it worsens, stop using this medication and consult your doctor or pharmacist. If you think you may have a serious medical problem, get medical help right away.
Precautions Necessary for Fluticasone Use
WebMD describes some of the precautions, as well.
“Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness / injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Though it is unlikely, this medication may slow down a child’s growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child’s height can be checked. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.”
Anyone who has experienced problems with Fluticasone Propionate Nasal Spray USP should contact his or her physician immediately. The affected product’s label reads “50 mcg per spray 120 Metered Sprays.” It was distributed to wholesalers, including Sam’s Club and Walmart, nationwide.
“When inhaling nasal spray, glass probably tops the list of things you hope aren’t accidently in the bottle,” Healthcare Packaging states in an article on its Web site titled “Nasal Spray Recalled After Packaging Found to Contain Glass Particles.” “According to a recent FDA news release, Apotex Corp. has voluntarily recalled one lot of Fluticasone Propionate Nasal Spray for just that reason.”
Consumers who have questions about the recall are encouraged to reach out to Apotex Corp. at (800) 706-5575 or at email@example.com. Healthcare professionals are encouraged report adverse events to the FDA MedWatch program at fda.gov/medwatch A form also can be obtained by calling (800) 332-1088.