Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Akorn | Location not on file | Makes it, tests it, packages it, labels it and sterilizes it | Not inspected on record |
Recalls
- Oct 13, 2022 · Class II · Akorn, Inc.
CGMP Deviations:
Lots: Lot: (a) 0A02B, 0A02D, 0A02C, 0A02A, 0A02E, EXP 12/31/2022; 0B60C, 0B46B, 0B60D EXP 1/31/2023; 0B67B, 0B67D, 0B60B, 0B60A, 0B67A, 0B46D, 0B67C, 0B46A, EXP 1/31/2023; 0C78B, 0C78D, 0C78C, EXP 2/28/2023; 0D11A, 0D11C, 0D11B, 0D11D, EXP 3/31/2023 0E35C, 0E35B, 0E35A, EXP 4/30/2023; 0J63B, 0J63C, EXP … - Aug 31, 2022 · Class II · Akorn, Inc.
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Lots: Lot # 9J36A, 9J36B, 9J39A, 9J39B, 9J39C, 9J39D, 9J39E, 9J42B, 9J42C, Exp 8/31/2022; 9K62A, 9K62B, 9K62C, Exp 9/30/2022; 9M04A, 9M04B, Exp 11/30/2022 - Sep 17, 2019 · Class II · Akorn, Inc.
cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
Lots: Lot #: 9B21A, Exp. 1/2022
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
- jelly
- Strength
- 20 mg per 1 mL
- Approval
- ANDA ANDA040433
- On the market since
- Aug 1, 2003
- Package NDCs
17478-711-1017478-711-3017478-711-31- Official label
- DailyMed (National Library of Medicine), updated Sep 12, 2022
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?