Status
Ongoing
Drug Enforcement D-0349-2024
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Classification
Class II
Report Date
March 6, 2024
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 59,712 bottles
- Reason for recall
- CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Golden State Medical Supply Inc.
- Address
-
5187 Camino Ruiz
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0349-2024
- Event ID
- 94029
- Recall initiation date
- February 14, 2024
- Center classification date
- February 23, 2024
- Code info
- Lot #: TX5275, Exp. Date: 10/31/2026.
- More code info
- —