Recalls / Class II
Class IID-0326-2024
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
- Brand name
- Fluticasone Propionate
- Generic name
- Fluticasone Propionate
- Active ingredient
- Fluticasone Propionate
- Route
- Nasal
- NDC
- 60505-0829
- FDA application
- ANDA077538
- Affected lot / code info
- Lot number # TX5274 Exp. 09/30/2026
Why it was recalled
CGMP Deviations: potential presence of Burkholderia cepacia complex
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, N/A, Weston, Florida 33326-3253
Distribution
- Quantity
- 292,752 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-02-09
- FDA classified
- 2024-02-16
- Posted by FDA
- 2024-02-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0326-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.