Product Safety Recalls

Product Recall Tracker

LIDOCAINE Recall D-1047-2022

Description: Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 gram tubes, Rx only, MFG: Sandoz Pharma, NDC 0168-0357-56

LIDOCAINE Recall D-1047-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1047-2022
Event ID89646
BrandLIDOCAINE AND PRILOCAINE
Generic NameLIDOCAINE AND PRILOCAINE
ManufacturerLIDOCAINE AND PRILOCAINE
Original Package?1
Active SubstanceLIDOCAINE PRILOCAINE
Drug RouteTOPICAL
DistributionUSA nationwide.
Quantity23 tubes
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0168-0357
Product NUIN0000175682 M0000897 N0000175426
Drug UPC0301680357300
Pharma Class (PE)Local Anesthesia [PE]
Pharma Class (EPC)Amide Local Anesthetic [EPC]
Pharma Class (CS)Amides [CS]
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient Identifier98PI200987 046O35D44R
Drug Application NumberANDA076453
Structured Product Labeling (SPL ID)01ee03aa-5444-4e90-9d08-9c3506a3bae0
Structured Product Labeling (SPL Set ID)833cd52c-6470-49c4-937f-1393971f4db9
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