Recalls / Class II
Class IID-0349-2024
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
- Brand name
- Fluticasone Propionate
- Generic name
- Fluticasone Propionate
- Active ingredient
- Fluticasone Propionate
- Route
- Nasal
- NDC
- 60429-195
- FDA application
- ANDA077538
- Affected lot / code info
- Lot #: TX5275, Exp. Date: 10/31/2026.
Why it was recalled
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Manufacturer
- Golden State Medical Supply, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, Camarillo, California 93012-8601
Distribution
- Quantity
- 59,712 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-02-14
- FDA classified
- 2024-02-23
- Posted by FDA
- 2024-03-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0349-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.