Fluticasone Propionate Spray, Metered
FDA Recall NDC 60429-195
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Fluticasone Propionate (NDC 60429-195). A significant event, classified as Class II, was initiated on Feb 14, 2024 by Golden State Medical Supply, Inc.. The reported reason for this action was: "CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Feb 14, 2024
Mar 06, 2024
59,712 bottles
Recall Profile & Regulatory Data
Event ID
94029
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# : TX5275, Exp. Date: 10/31/2026.
Affected Packages Involved in this Recall
60429-195-15Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
