NDC 84549-922
Aminophylline 25 mg per 1 mL injection, solution
On the label: ProPharma Distribution. It's repackaged: ProPharma Distribution rebottles it from Hospira, Inc.'s NDC 0409-5922.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hospira, Inc. | Rocky Mount, NC, United States | Makes it, tests it, packages it and labels it | No problems foundFeb 7, 2025 · 11 inspections, 3 with FDA action |
Repackaging site
- ProPharma Distribution, Westminster, CO, United States · repackages it and relabels it
Recalls
- Sep 27, 2022 · Class II · Pfizer Inc.
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Lots: Lot: 30-137-DK Exp. 1 DEC. 2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Theophylline: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 25 mg per 1 mL
- Approval
- ANDA ANDA087242
- On the market since
- Feb 28, 2005
- Package NDCs
84549-922-01- Official label
- DailyMed (National Library of Medicine), updated Dec 18, 2025
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