D-0349-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- March 6, 2024
- Initiation Date
- February 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59,712 bottles
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
Reason for Recall
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: TX5275, Exp. Date: 10/31/2026.