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

Mandated?Voluntary: Firm initiated
Recall NumberD-1329-2022
Event ID90637
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
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