Corticosteroid, Histamine-1 Receptor Antagonist
Where is Azelastine and Fluticasone made?
5 companies sell it under their own name and 1 repackager rebottle it. None of their labels names the factory.
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Apotex Corp.50 ug / 137 ug · NDC 60505-0953 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.50 ug / 137 ug · NDC 0378-3458 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd50 ug / 137 ug · NDC 45802-066 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.50 ug / 137 ug · NDC 0480-2157 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Viatris Specialty LLC Dymista50 ug / 137 ug · NDC 0037-0245 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Azelastine and Fluticasone in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Bryant Ranch Prepack:
63629-8612,72162-1388
Recalls
- Feb 1, 2019 · Class II · Mylan Pharmaceuticals Inc.
Defective Container: Potential for broken glass in the neck area of the glass bottles. - Jul 25, 2018 · Class II · Mylan Pharmaceuticals Inc.
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.