Drug Safety Alerts

Fluticasone Propionate Nasal Spray 50 mcg Consumer-Level Recall

5/31/18

On May 31, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding a consumer-level recall of fluticasone propionate nasal spray 50 mcg NDC # 60505-0829-01 manufactured by Apotex Corp. This recall was issued because the product was found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump.

This recall affects lot number NJ4501 exp. 07/20.

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. To date, Apotex Corp. has not received any reports of adverse events related to recall.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using fluticasone propionate nasal spray 50 mcg to contact their prescriber.

For more information about this recall, please call Apotex toll-free at 1-800-706-5575, Monday through Friday, 8:30am to 5:00pm (ET). You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit at https://www.fda.gov.