Product Safety Recalls

Product Recall Tracker

LAMOTRIGINE Recall D-1329-2022

Description: Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4

LAMOTRIGINE Recall D-1329-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1329-2022
Event ID90637
BrandLAMOTRIGINE
Generic NameLAMOTRIGINE
ManufacturerLAMOTRIGINE
Active SubstanceLAMOTRIGINE
Drug RouteORAL
DistributionNationwide within the United States
Quantity8328 bottles
Recall ReasonLabeling: Label Error on Declared Strength
Drug ClassificationClass III
Drug Code Info20220817
Product NDC42291-366 42291-367 42291-368
Product NUIN0000175753 N0000008486 N0000175751
Drug UPC0342291368606 342291367104
Pharma Class (PE)Decreased Central Nervous System Disorganized Electrical Activity [PE]
Pharma Class (EPC)Anti-epileptic Agent [EPC]
Recall Initiation Date20220720
Report Date20220817
Classification Date20220808
Address615 N 1st St
Pulaski, TN 38478-2403
United States
Recalling FirmAVKARE Inc.
Initial Notification Letter
Unique Ingredient IdentifierU3H27498KS
Drug Application NumberANDA079132
Structured Product Labeling (SPL ID)d57af4f3-6350-5f6c-e053-2995a90a15a4
Structured Product Labeling (SPL Set ID)fcdb94a8-33be-6375-98ef-6933999d157f
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.