Corticosteroid, beta2-Adrenergic Agonist
Where is Budesonide and Formoterol made?
4 companies sell it under their own name and 3 repackagers rebottle it. None of their labels names the factory.
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| AstraZeneca Pharmaceuticals LP Symbicort80 ug / 4.5 ug, 160 ug / 4.5 ug · NDC 0186-0370, 0186-0372 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AstraZeneca Pharmaceuticals LP80 ug / 4.5 ug, 160 ug / 4.5 ug · NDC 0310-7370, 0310-7372 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.80 ug / 4.5 ug, 160 ug / 4.5 ug · NDC 0378-7503, 0378-7502 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.80 ug / 4.5 ug, 160 ug / 4.5 ug · NDC 0480-3081, 0480-3080 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Budesonide and Formoterol 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.
- A-S Medication Solutions:
50090-6327,50090-4508,50090-4509,50090-1403+2 - RPK Pharmaceuticals, Inc.:
53002-2667,53002-2666 - Sportpharm LLC:
85766-114,85766-184,85766-113
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.