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LIDOCAINE HYDROCHLORIDE Recall D-1495-2022

Description: Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31

LIDOCAINE HYDROCHLORIDE Recall D-1495-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1495-2022
Event ID90813
BrandLIDOCAINE
Generic NameLIDOCAINE HYDROCHLORIDE
ManufacturerLIDOCAINE HYDROCHLORIDE
Original Package?1
Active SubstanceLIDOCAINE HYDROCHLORIDE
Drug RouteTOPICAL
DistributionUSA nationwide
Quantity82,689 tubes
Recall ReasoncGMP 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.
Drug ClassificationClass II
Drug Code Info20220914
Product NDC17478-711
Drug UPC0317478711100
Recall Initiation Date20220831
Report Date20220914
Classification Date20220906
Address5605 Centerpoint Ct Ste A
Gurnee, IL 60031-5278
United States
Recalling FirmAkorn, Inc.
Initial Notification Letter
Unique Ingredient IdentifierV13007Z41A
Drug Application NumberANDA040433
Structured Product Labeling (SPL ID)cabfb396-7b14-40b5-a647-634e907e2d3c
Structured Product Labeling (SPL Set ID)317a8784-5fdd-429f-9b74-14d89f372a32
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