Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Dymista (azelastine hydrochloride and fluticasone propionate)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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.
Affected NDC
0037-0245-23
Compare with the code on your package — it is the most precise check available.
Drug: Fluticasone Category: Allergy & Cold Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Dymista Azelastine Hydrochloride and Fluticasone Propionate NDC 00037-0245 |
AZELASTINE HYDROCHLORIDE 137 ug/1; FLUTICASONE PROPIONATE 50 ug/1 | Spray, Metered Nasal |
Viatris Specialty LLC | Rx |
- Recalling firm
- Mylan Pharmaceuticals Inc.
- NDC code
- 0037-0245-23
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0424-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fluticasone recalls
See all
Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP 50mcg
CGMP Deviations: potential presence of Burkholderia cepacia complex
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
Defective container: defect prevents product from dispensing as intended.
Class II · Moderate risk
Inhub Wixela
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Other recalls by Mylan Pharmaceuticals Inc.
All 2019 recalls
Class II · Moderate risk
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Class II · Moderate risk
Prasugrel Tablets
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Class II · Moderate risk
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Class II · Moderate risk
Mycophenolate Mofetil for Injection USP
Presence of precipitate
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