NDC 61919-774
Lidocaine 50 mg per 1 g ointment
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Teligent Pharma, Inc.'s NDC 52565-008.
Where the pills inside were 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 |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · relabels it
Recalls
- Mar 15, 2022 · Class II · Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Lots: Batch: 16389, Exp. 2/29/2024; 16452, Exp. 2/29/2024 - Jul 29, 2021 · Class III · Teligent Pharma, Inc.
Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Lots: Lot #: 15378, Exp 3/2023; 14418 EXP 10/2021 - Mar 29, 2021 · Class III · Teligent Pharma, Inc.
Failed Stability Specifications: product did not meet viscosity results.
Lots: Lot 13269, Exp March 2021
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
- ointment
- Strength
- 50 mg per 1 g
- Approval
- ANDA ANDA205318
- On the market since
- Apr 1, 2019
- Package NDCs
61919-774-3561919-774-50- Official label
- DailyMed (National Library of Medicine), updated May 18, 2023
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