Product Safety Recalls

Product Recall Tracker

LIDOCAINE Recall D-0794-2022

Description: Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA

LIDOCAINE Recall D-0794-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0794-2022
Event ID89944
BrandLIDOCAINE AND PRILOCAINE
Generic NameLIDOCAINE AND PRILOCAINE
ManufacturerLIDOCAINE AND PRILOCAINE
Original Package?1
Active SubstanceLIDOCAINE PRILOCAINE
Drug RouteTOPICAL
DistributionNationwide within the United States
Quantity353964 units
Recall ReasoncGMP Deviations
Drug ClassificationClass II
Drug Code Info20220504
Product NDC0591-2070 59088-767
Product NUIN0000175682 M0000897 N0000175426
Drug UPC0352817330109
Pharma Class (PE)Local Anesthesia [PE]
Pharma Class (EPC)Amide Local Anesthetic [EPC]
Pharma Class (CS)Amides [CS]
Recall Initiation Date20220415
Report Date20220504
Classification Date20220427
Address400 Interpace Pkwy Bldg A
Parsippany, NJ 07054-1120
United States
Recalling FirmTeva Pharmaceuticals USA Inc
Unique Ingredient Identifier98PI200987 046O35D44R
Drug Application NumberNDA019941
Structured Product Labeling (SPL ID)c1d83f9e-e4ab-4d6b-ae19-e08464b4afd1
Structured Product Labeling (SPL Set ID)1972d657-2d5a-4697-bba9-80caffc2f2d7
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