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LIDOCAINE HYDROCHLORIDE ANHYDROUS Recall D-0846-2022

Description: Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04

LIDOCAINE HYDROCHLORIDE ANHYDROUS Recall D-0846-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0846-2022
Event ID89993
BrandLIDOCAINE HYDROCHLORIDE
Generic NameLIDOCAINE HYDROCHLORIDE
ManufacturerLIDOCAINE HYDROCHLORIDE
Original Package?1
Active SubstanceLIDOCAINE HYDROCHLORIDE ANHYDROUS
Drug RouteORAL
DistributionNationwide USA and Puerto Rico
Quantity66,744 bottles
Recall ReasonFailed viscosity specification - product was below specificcation
Drug ClassificationClass III
Drug Code Info20220511
Product NDC50383-775
Recall Initiation Date20220415
Report Date20220511
Classification Date20220505
Address1925 W Field Ct Ste 300
Lake Forest, IL 60045-4862
United States
Recalling FirmAkorn, Inc.
Initial Notification Letter
Unique Ingredient IdentifierEC2CNF7XFP
Drug Application NumberANDA040014
Structured Product Labeling (SPL ID)c98571bd-002b-4745-b27e-3b11e6a3af47
Structured Product Labeling (SPL Set ID)ff6b27bc-2ed7-4292-b8c8-da910bf68167
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