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
FDA recall notice · announced March 6, 2024 · Golden State Medical Supply
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
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
Notes
Distribution: Nationwide in the USA
Lot/code information: Lot #: TX5275, Exp. Date: 10/31/2026.
Quantity: 59,712 bottles
Status: Ongoing
Products in this recall event:
- 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 (D-0349-2024)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.