Apotex Voluntarily Recalls Fluticasone Propionate Nasal Spray
May 31, 2018 – Apotex Corp. has voluntarily recalled Lot NJ4501 of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 metered sprays. The recall follows a customer complaint, which led to the discovery of small glass particles that can block the actuator and interfere with proper function of the spray.
Although Apotex has not received reports of any adverse events associated with the recalled product, there is potential for consumers who use the affected product to be exposed to glass particles that could damage the mucous membrane inside nasal passages.
Apotex notified wholesalers and distributors of the voluntary recall by letter. A limited number of BeneCard PBF members who use the mail order and specialty pharmacy, Benecard Central Fill, were affected. The pharmacy notified these members of the recall and provided replacements for members who were still using the affected product.
Consumers whose Fluticasone Propionate Nasal Spray is affected by the recall should discontinue use of the recalled product immediately. Questions regarding the recall can be directed to Apotex at 1-800-706-5575 or UScustomerservice@Apotex.com. Patients who experience any issues that may be related to the recalled nasal spray should contact their healthcare providers.
Adverse events or problems with the product can also be reported to the FDA’s MedWatch Program.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.