NDC 43066-360
Nexterone 1.8 mg per 1 mL injection, solution
On the label: Baxter Healthcare Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation | Round Lake, IL, United States | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action |
Recalls
- Aug 6, 2026 · Class II · Baxter Healthcare Corporation
CGMP Deviations
Lots: Lot # NC177832, Exp Date: 12/31/2026; Lot # NC185417, NC185455, Exp Date: 08/31/2027; Lot # NC188593, Exp Date: 11/30/2027; Lot # NC188647, NC188685, NC188807, NC188838, NC188920, Exp Date: 12/31/2027; Lot # NC193603, NC193726, NC193788, NC193863, NC193900, Exp Date: 04/30/2028; Lot # NC194082, NC1… - Nov 10, 2017 · Class I · Baxter Healthcare Corporation
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Lots: Lot #, Expiry: NC109925, Exp 6/1/2019; NC109123, 5/2019
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
- 1.8 mg per 1 mL
- Approval
- NDA NDA022325
- On the market since
- Nov 16, 2010
- Package NDCs
43066-360-20- Official label
- DailyMed (National Library of Medicine), updated Apr 16, 2024
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