NDC 50090-0555

Lidocaine 20 mg per 1 mL jelly

On the label: A-S Medication Solutions. It's repackaged: A-S Medication Solutions rebottles it from Akorn's NDC 17478-711.

Where the pills inside were 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

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.

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: 50090-0555-0
Official label: DailyMed (National Library of Medicine), updated Apr 14, 2021

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