Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx o...
FDA Recall #D-0349-2024 — Class II — February 14, 2024
Product Description
Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15
Reason for Recall
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Recalling Firm
Golden State Medical Supply Inc. — Camarillo, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
59,712 bottles
Distribution
Nationwide in the USA
Code Information
Lot #: TX5275, Exp. Date: 10/31/2026.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated