Drug 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
D-0349-2024
Product summary
- Event
- Event 94029
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 59,712 bottles
- Official record key
drug-enforcement:D-0349-2024
Official wording
Reason: CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Code information: Lot #: TX5275, Exp. Date: 10/31/2026.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
presence of Burkholderia cepacia