NDC 84549-018
Epinephrine 0.1 mg per 1 mL injection
On the label: ProPharma Distribution. It's repackaged: ProPharma Distribution rebottles it from International Medication Systems, Ltd.'s NDC 76329-3318.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| International Medication Systems, Ltd. | South El Monte, CA, United States | Makes it and tests it | Serious problems, FDA actionDec 19, 2025 · 15 inspections, 1 with FDA action |
Repackaging site
- ProPharma Distribution, Westminster, CO, United States · repackages it and relabels it
Recalls
- Apr 1, 2026 · Class II · International Medication Systems Ltd.
Lack of Assurance of Sterility
Lots: Lot Number: EA038A5, Expiration Date: 08/2026.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Epinephrine: every company that makes it
- Form
- injection, intravenous
- Strength
- 0.1 mg per 1 mL
- Approval
- NDA NDA211363
- On the market since
- Jan 30, 2023
- Package NDCs
84549-018-01- Official label
- DailyMed (National Library of Medicine), updated Aug 28, 2025
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