Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Melrose Park, IL, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
Recalls
- Jul 16, 2026 · Class II · Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in product
Lots: Lot #: 6134349, 6134620 Exp. Date 11/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Glycopyrronium: every company that makes it
- Form
- injection, solution, intramuscular; intravenous
- Strength
- 0.2 mg per 1 mL
- Approval
- ANDA ANDA209328
- On the market since
- Oct 27, 2017
- Package NDCs
63323-578-1163323-578-1263323-578-4163323-578-42- Official label
- DailyMed (National Library of Medicine), updated Oct 14, 2024
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