Drug product
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
D-0326-2024
Product summary
- Firm
- Apotex Corp.
- Event
- Event 93974
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 292,752 bottles
- Official record key
drug-enforcement:D-0326-2024
Official wording
Reason: CGMP Deviations: potential presence of Burkholderia cepacia complex
Code information: Lot number # TX5274 Exp. 09/30/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
presence of Burkholderia cepacia