Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| American Regent, Inc. | Hilliard, OH, United States | Makes it | Problems found, fixed voluntarilyJun 18, 2026 · 8 inspections |
Recalls
- Aug 11, 2026 · Class I · American Regent, Inc.
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Lots: Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027
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, intramuscular; intravenous; subcutaneous
- Strength
- 1 mg per 1 mL
- Approval
- ANDA ANDA217192
- On the market since
- Oct 9, 2024
- Package NDCs
0517-3030-01- Official label
- DailyMed (National Library of Medicine), updated Apr 1, 2023
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