Dymista Spray, Metered
FDA Recall NDC 0037-0245
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Dymista (NDC 0037-0245). A significant event, classified as Class II, was initiated on Feb 01, 2019 by Viatris Specialty Llc. The reported reason for this action was: "Defective Container: Potential for broken glass in the neck area of the glass bottles."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Feb 01, 2019
Feb 13, 2019
10,390 bottles
Recall Profile & Regulatory Data
Event ID
81980
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Sep 09, 2019
Product Description
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.
Batch or Lot Expiration Information
Lot# Lot: GA70535, Exp. April 2019
Affected Packages Involved in this Recall
0037-0245-23Product
Class II Terminated
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Jul 25, 2018
Aug 15, 2018
20,780 bottles
Recall Profile & Regulatory Data
Event ID
77850
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Aug 15, 2019
Product Description
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23
Batch or Lot Expiration Information
Lot# : GA70246, GA70254, Exp 02/2019
Affected Packages Involved in this Recall
0037-0245-23Product
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.
