Fluticasone Propionate Spray, Metered
FDA Recall NDC 60505-0829
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Fluticasone Propionate (NDC 60505-0829). A significant event, classified as Class II, was initiated on Feb 09, 2024 by Apotex Corp.. The reported reason for this action was: "CGMP Deviations: 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: potential presence of Burkholderia cepacia complex
Feb 09, 2024
Feb 28, 2024
292,752 bottles
Recall Profile & Regulatory Data
Event ID
93974
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1
Batch or Lot Expiration Information
Lot# Lot number # TX5274 Exp. 09/30/2026
Affected Packages Involved in this Recall
60505-0829-1Product
Class II Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Jan 26, 2022
Jan 03, 2024
6 units
Recall Profile & Regulatory Data
Event ID
89450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CARDINAL HEALTHCARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 29, 2024
Product Description
Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1
Batch or Lot Expiration Information
Batch# Batch TE9159, TE8156
Affected Packages Involved in this Recall
60505-0829-1Product
Class II Terminated
Presence of foreign substance: glass particles
May 31, 2018
Jun 13, 2018
Unknown
Recall Profile & Regulatory Data
Event ID
80202
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Apotex Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 28, 2022
Product Description
Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1
Batch or Lot Expiration Information
Lot# Lot: NJ4501 Exp. 07/2020
Affected Packages Involved in this Recall
60505-0829-1Product
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.
