Product Safety Recalls

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LIDOCAINE Recall D-0849-2022

Description: Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66

LIDOCAINE Recall D-0849-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0849-2022
Event ID89986
BrandLIDOCAINE AND PRILOCAINE
Generic NameLIDOCAINE AND PRILOCAINE
ManufacturerLIDOCAINE AND PRILOCAINE
Original Package?1
Active SubstanceLIDOCAINE PRILOCAINE
Drug RouteTOPICAL
DistributionNationwide in the United States including Guam and the Northern Mariana Islands.
Quantity1176 tubes
Recall ReasonCGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Drug ClassificationClass II
Drug Code Info20220511
Product NDC63739-054
Product NUIN0000175682 M0000897 N0000175426
Drug UPC0363739054660
Pharma Class (PE)Local Anesthesia [PE]
Pharma Class (EPC)Amide Local Anesthetic [EPC]
Pharma Class (CS)Amides [CS]
Recall Initiation Date20220421
Report Date20220511
Classification Date20220505
Address4853 Crumpler Rd
Memphis, TN 38141-8301
United States
Recalling FirmMcKesson Corporation dba McKesson Drug Company
Initial Notification Letter
Unique Ingredient Identifier98PI200987 046O35D44R
Drug Application NumberANDA205887
Structured Product Labeling (SPL ID)9b924815-f957-45d0-b4b4-44a8c41aa7b8
Structured Product Labeling (SPL Set ID)f31fc5e2-d7ff-4381-ba23-d4b25e5b430b
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