NDC 55150-295
Glycopyrrolate 0.2 mg per 1 mL injection, solution
On the label: AuroMedics Pharma LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Eugia Pharma Specialities Limited | Sangareddy, India | Makes it and tests it | Serious problems, FDA actionFeb 6, 2026 · 7 inspections, 2 with FDA action |
Recalls
- Feb 7, 2020 · Class III · AuroMedics Pharma LLC
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Lots: Lot #CGP190001-A, Exp. 07/31/2020
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 ANDA210244
- On the market since
- Nov 28, 2018
- Package NDCs
55150-295-20- Official label
- DailyMed (National Library of Medicine), updated Dec 22, 2021
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