Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manu...
FDA Recall #D-0326-2024 — Class II — February 9, 2024
Product Description
Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1
Reason for Recall
CGMP Deviations: potential presence of Burkholderia cepacia complex
Recalling Firm
Apotex Corp. — Weston, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
292,752 bottles
Distribution
Nationwide in the USA
Code Information
Lot number # TX5274 Exp. 09/30/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated