Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Teligent Pharma, Inc. | Buena, New Jersey, United States | Makes it | Serious problems, FDA actionAug 31, 2021 · 8 inspections, 1 with FDA action |
Recalls
- Oct 12, 2021 · Class I · Teligent Pharma, Inc.
Superpotent Drug
Lots: Lot #: 13262, Exp. 03/2022; 14217, Exp. 08/2022 - Oct 12, 2021 · Class II · Teligent Pharma, Inc.
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Lots: Lot #: 13058, Exp. date 02/2022 and 13768, Exp. date 05/2022 - Aug 3, 2021 · Class I · Teligent Pharma, Inc.
Superpotent Drug
Lots: Lot #:14218, Exp. Date 08/2022
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
- solution
- Strength
- 40 mg per 1 mL
- Approval
- ANDA ANDA204494
- On the market since
- Mar 18, 2014
- Package NDCs
52565-009-50- Official label
- DailyMed (National Library of Medicine), updated Dec 5, 2019
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