Product Safety Recalls

Product Recall Tracker

LIDOCAINE Recall D-0704-2022

Description: Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28.

LIDOCAINE Recall D-0704-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0704-2022
Event ID89798
BrandLIDOCAINE 4% CREAM
Generic NameLIDOCAINE
ManufacturerLIDOCAINE
Original Package?1
Active SubstanceLIDOCAINE
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity48,907 tubes
Recall ReasoncGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Drug ClassificationClass II
Drug Code Info20220330
Product NDC0536-1281
Product NUIN0000175682 M0000897 N0000175426
Pharma Class (PE)Local Anesthesia [PE]
Pharma Class (EPC)Amide Local Anesthetic [EPC]
Pharma Class (CS)Amides [CS]
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Unique Ingredient Identifier98PI200987
Drug Application Numberpart348
Structured Product Labeling (SPL ID)b83d3c7a-5f3d-445f-aedb-4bb40549688d
Structured Product Labeling (SPL Set ID)21ea06f4-813e-419e-9b87-1eb04d48097e
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