D-0349-2024 Class II Ongoing
FDA drug recall D-0349-2024 was initiated by Golden State Medical Supply Inc. on Feb 14, 2024 and is designated Class II. Reason for recall: CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex The recall status is ongoing. Affected quantity: 59,712 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 6, 2024
- Initiation Date
- Feb 14, 2024
- 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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0349-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026