NDC 55150-180
Amiodarone Hydrochloride 150 mg per 3 mL injection, solution
On the label: AuroMedics Pharma LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alivus Life Sciences Limited | Ankleshwar, India | Makes the active ingredient | Problems found, fixed voluntarilyJan 31, 2025 · 5 inspections |
| Eugia Pharma Specialities Limited | Sangareddy, India | Makes it and tests it | Serious problems, FDA actionFeb 6, 2026 · 7 inspections, 2 with FDA action |
Recalls
- Nov 11, 2019 · Class III · AuroMedics Pharma LLC
Crystallization: Presence of visible particulate matter.
Lots: Lot# CAH180009, exp. date Feb 2020 - Nov 11, 2019 · Class III · AuroMedics Pharma LLC
Crystallization: Presence of visible particulate matter.
Lots: Lot# CAH180001, exp. date Jan 2020; CAH180003, exp. date Feb 2020; CAH180011, CAH180012, exp. date Jun 2020 - Nov 11, 2019 · Class III · AuroMedics Pharma LLC
Crystallization: Presence of visible particulate matter.
Lots: Lot#: CAH180013, CAH180014, exp. date Jul 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
- Amiodarone: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 150 mg per 3 mL
- Approval
- ANDA ANDA204550
- On the market since
- Oct 25, 2017
- Package NDCs
55150-180-03- Official label
- DailyMed (National Library of Medicine), updated Dec 8, 2021
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