Lamotrigine Tablet
FDA Recall NDC 42291-367
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Lamotrigine (NDC 42291-367). A significant event, classified as Class III, was initiated on Jul 20, 2022 by Avkare. The reported reason for this action was: "Labeling: Label Error on Declared Strength"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Label Error on Declared Strength
Jul 20, 2022
Aug 17, 2022
8328 bottles
Recall Profile & Regulatory Data
Event ID
90637
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
AVKARE Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Sep 30, 2024
Product 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
Batch or Lot Expiration Information
Lot# : 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022
Affected Packages Involved in this Recall
42291-366-01Product
42291-366-10Product
42291-367-01Product
42291-367-10Product
42291-368-60Product
42291-368-50Product
42291-369-60Product
42291-369-50Product
May 2020 Class III Recall: Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Recall Number
Class III Terminated
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
May 28, 2020
Jun 10, 2020
4124 bottles
Recall Profile & Regulatory Data
Event ID
85783
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
AVKARE Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Oct 22, 2021
Product Description
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.
Batch or Lot Expiration Information
Lot# : a) 25634, b) 25633; Exp. 09/30/2021
Affected Packages Involved in this Recall
42291-366-01Product
42291-366-10Product
42291-367-01Product
42291-367-10Product
42291-368-60Product
42291-368-50Product
42291-369-60Product
42291-369-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
