NDC 65282-1605
Lidocaine Hydrochloride 10 mg per 1 mL injection, solution
On the label: Spectra Medical Deviecs, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Delta Synthetic Co., Ltd. | Tucheng District, Taiwan | Makes the active ingredient | No problems foundMay 29, 2025 · 6 inspections |
| Huons Co., Ltd. | Jecheon-si, South Korea | Makes it | Serious problems, FDA actionNov 21, 2025 · 3 inspections, 1 with FDA action |
Recalls
- May 12, 2026 · Class II · Spectra Medical Devices, Llc
Lack of Assurance of Sterility
Lots: Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Lidocaine: every company that makes it
- Form
- injection, solution, epidural; infiltration; intracaudal; perineural
- Strength
- 10 mg per 1 mL
- Approval
- ANDA ANDA208017
- On the market since
- Apr 18, 2018
- Package NDCs
65282-1605-1- Official label
- DailyMed (National Library of Medicine), updated Jan 12, 2024
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