NDC 84549-001
Atropine Sulfate 1 mg per 1 mL injection, solution
On the label: ProPharma Distribution. It's repackaged: ProPharma Distribution rebottles it from American Regent, Inc.'s NDC 0517-1001.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| American Regent, Inc. | Shirley, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyApr 24, 2024 · 12 inspections, 1 with FDA action |
Repackaging site
- ProPharma Distribution, Westminster, CO, United States · repackages it and relabels it
Recalls
- Jul 24, 2026 · Class II · American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Lots: Lot #: 24353, Exp. Date: 9/30/2026.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Atropine: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 1 mg per 1 mL
- Approval
- ANDA ANDA216120
- On the market since
- Aug 2, 2022
- Package NDCs
84549-001-25- Official label
- DailyMed (National Library of Medicine), updated Sep 17, 2025
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