Product Safety Recalls

Product Recall Tracker

LIDOCAINE Recall D-0556-2023

Description: Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA

LIDOCAINE Recall D-0556-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0556-2023
Event ID92161
Active SubstanceLIDOCAINE
DistributionNationwide in the USA
Quantity403 boxes
Recall ReasonLabeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Drug ClassificationClass III
Drug Code Info20230510
Product NDC63629-8755
Product NUIN0000175682 M0000897 N0000175426
Pharma Class (PE)Local Anesthesia [PE]
Pharma Class (EPC)Amide Local Anesthetic [EPC]
Pharma Class (CS)Amides [CS]
Recall Initiation Date20230420
Report Date20230510
Classification Date20230428
Address1919 N Victory Pl
Burbank, CA 91504-3425
United States
Recalling FirmBryant Ranch Prepack, Inc.
Initial Notification Letter
Unique Ingredient Identifier98PI200987
Drug Application NumberANDA200675
Structured Product Labeling (SPL ID)3213bb03-7987-4a97-8423-708f064d1f2c
Structured Product Labeling (SPL Set ID)1d28d687-695e-4cd9-97e2-7d4fdab9772a
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