Asmanex Inhalant
FDA Recall NDC 78206-115
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 Asmanex (NDC 78206-115). A significant event, classified as Class III, was initiated on May 28, 2024 by Organon Llc. The reported reason for this action was: "Defective Container"
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 III Ongoing
Defective Container
May 28, 2024
Jun 19, 2024
2,886 units
Recall Profile & Regulatory Data
Event ID
94703
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Organon Llc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-02
Batch or Lot Expiration Information
Lot# : X025346, Exp 3/3/2025
Affected Packages Involved in this Recall
78206-114-03Product
78206-114-04Product
78206-114-02Product
78206-114-01Product
78206-114-59Product
78206-115-59Product
78206-115-01Product
Class III Ongoing
Defective Container
May 28, 2024
Jun 19, 2024
2,551 units
Recall Profile & Regulatory Data
Event ID
94703
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Organon Llc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-03
Batch or Lot Expiration Information
Lot# : X024051, Exp 04/25/2025
Affected Packages Involved in this Recall
78206-114-03Product
78206-114-04Product
78206-114-02Product
78206-114-01Product
78206-114-59Product
78206-115-59Product
78206-115-01Product
Class II Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Jan 26, 2022
Jan 03, 2024
3 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
Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore. NDC: 78206-114-01
Batch or Lot Expiration Information
Batch# Batch U027458
Affected Packages Involved in this Recall
78206-114-03Product
78206-114-04Product
78206-114-02Product
78206-114-01Product
78206-114-59Product
78206-115-59Product
78206-115-01Product
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.
